<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd">
<html>
<head>
<title>
kmph-8k_20151021.htm
</title>
</head>
<!-- NG Converter v4.0.2.6 -->
<body>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:4pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:1pt;">&nbsp;</p>
<p style="text-align:center;line-height:1pt;border-top:Solid 0.75pt #000000;padding-top:0pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:1pt;line-height:1pt;border-top:Solid 1pt;padding-top:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">UNITED STATES</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SECURITIES AND EXCHANGE COMMISSION</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">WASHINGTON, D.C. 20549 </p>
<p style="text-align:center;margin-top:9pt;line-height:4pt;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">FORM 8-K </p>
<p style="text-align:center;margin-top:9pt;line-height:4pt;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CURRENT REPORT </p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 </p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Date of Report (Date of earliest event reported): October 21, 2015</p>
<p style="text-align:center;margin-top:9pt;line-height:4pt;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:24pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">KEMPHARM, INC.</font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Exact name of Registrant as Specified in Its Charter) </p>
<p style="text-align:center;margin-top:9pt;line-height:4pt;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<div>
<table border="0" cellspacing="0" cellpadding="0" align="center" style="border-collapse:collapse; width:100%;">
<tr>
<td valign="bottom"  style="width:33.32%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">Delaware</font></p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">001-36913</font></p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">20-5894398</font></p></td>
</tr>
<tr>
<td valign="bottom"  style="width:33.32%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(State or Other Jurisdiction</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">of Incorporation)</p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Commission File Number)</p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(IRS Employer</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Identification No.)</p></td>
</tr>
<tr style="height:12pt;">
<td valign="bottom"  style="width:33.32%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
</tr>
<tr>
<td valign="bottom"  style="width:33.32%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">2656 Crosspark Road, Suite 100</font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">Coralville, IA</font></p></td>
<td valign="bottom"  style="padding-left:7.2pt;padding-Right:0pt;padding-Top:0pt;padding-Bottom:0pt;width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:12pt;">&nbsp;</p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">52241</font></p></td>
</tr>
<tr>
<td valign="bottom"  style="width:33.32%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Address of Principal Executive Offices)</p></td>
<td valign="bottom"  style="padding-left:7.2pt;padding-Right:0pt;padding-Top:0pt;padding-Bottom:0pt;width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
<td valign="bottom"  style="width:33.34%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(Zip Code)</p></td>
</tr>
</table></div>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Registrant&#8217;s Telephone Number, Including Area Code: <font style="Background-color:#FFFFFF;color:#000000;">(319) 665-2575</font></p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Not Applicable </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Former Name or Former Address, if Changed Since Last Report) </p>
<p style="text-align:center;margin-top:9pt;line-height:4pt;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below): </p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:4.54%;white-space:nowrap">
<p style="margin-top:9pt;margin-bottom:0pt;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font></p></td>
<td valign="top">
<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </font></p></td></tr></table></div>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:4.54%;white-space:nowrap">
<p style="margin-top:9pt;margin-bottom:0pt;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font></p></td>
<td valign="top">
<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </font></p></td></tr></table></div>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:4.54%;white-space:nowrap">
<p style="margin-top:9pt;margin-bottom:0pt;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font></p></td>
<td valign="top">
<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </font></p></td></tr></table></div>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:4.54%;white-space:nowrap">
<p style="margin-top:9pt;margin-bottom:0pt;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font></p></td>
<td valign="top">
<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </font></p></td></tr></table></div>
<p style="text-align:center;margin-top:4pt;line-height:1pt;border-top:Solid 0.75pt #000000;padding-top:0pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:1pt;line-height:1pt;border-top:Solid 1pt;padding-top:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>

<hr style="page-break-after:always;width:100%;">
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 7.01</font><font style="margin-left:36pt;">Regulation FD</font><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"> Disclosure</font><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">.</font>&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="S93736525"></a><a name="S47023450"></a>On October 21<a name="S93736525"></a>, 2015, <font style="color:#000000;">KemPharm, Inc., a Delaware corporation, or KemPharm, issued a press release regarding the items described in Item 8.01 below</font><a name="S47023450"></a>.<font style="color:#000000;"> A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in the press release furnished as Exhibit 99.1 shall not be deemed &#8220;filed&#8221; for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of KemPharm&#8217;s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 8.01<font style="margin-left:36pt;">Other Events.</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On October 21, 2015, KemPharm reported<font style="color:#000000;"> </font>top-line results from the KP201.A02 intranasal human abuse liability clinical trial<font style="font-size:12pt;">. </font>This trial was a phase 1 type clinical trial in 42 healthy, non-dependent recreational drug abusers, to determine the exposure, abuse potential, and safety of crushed intranasal (IN) KP201/APAP relative to crushed IN Norco&#174; (hydrocodone bitartrate/APAP). To highlight:</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-size:10pt;font-family:'Symbol';font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">IN KP201/APAP exhibited significant pharmacokinetic differences from IN Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup> due primarily to a significant increase in time to achieve peak exposure (T<sub style="font-size:85%; vertical-align:bottom">max</sub>)(p = 0.0001) and lower peak hydrocodone exposure (C<sub style="font-size:85%; vertical-align:bottom">max</sub>) for KP201/APAP (p = 0.0027).</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:12.93%;text-indent:0%;font-size:10pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:'Symbol';font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">IN KP201/APAP did not result in greater hydrocodone exposure and produced a similar pharmacokinetic profile compared to both KP201/APAP and Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup> taken orally.</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:'Symbol';font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Hydrocodone exposure through peak drug effect showed a statistically significant reduction for IN KP201/APAP vs. IN Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup>:</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:16.77%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Courier New;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:Courier New;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">o</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Courier New;font-size:10pt;"><font style="font-family:Times New Roman;">0-0.5 hour: 50.1% reduction (p = 0.0044);</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:20.62%;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:16.77%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Courier New;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:Courier New;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">o</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Courier New;font-size:10pt;"><font style="font-family:Times New Roman;">0-1.0 hour: 29.1% reduction (p = 0.0005); and</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:16.77%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Courier New;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:Courier New;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">o</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Courier New;font-size:10pt;"><font style="font-family:Times New Roman;">0-2.0 hours: 14.9% reduction (p = 0.0003).</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:'Symbol';font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Based on this reduced exposure to hydrocodone, drug liking through peak effect (2.0 hours) was significantly lower for IN KP201/APAP vs. IN Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup> (p&lt;0.0001).</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:12.93%;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:'Symbol';font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Mean peak drug liking (E<sub style="font-size:85%; vertical-align:bottom">max</sub>) was lower for KP201/APAP, both IN (75.9) and oral (76.9), compared to that of Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup> (79.0, IN; 77.9, oral), though liking scores were statistically similar for all treatments, which KemPharm believes was potentially due to the effects of APAP.</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:'Symbol';font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Median peak drug liking was lowest for IN KP201/APAP (74) and highest for IN Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup> (80).</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:'Symbol';font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Time to peak drug liking IN KP201/APAP was delayed (1.8 hours) compared to IN Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup> (1.0 hour), and was similar based on similar pharmacokinetics, to KP201/APAP and Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup> taken orally (2.0 hours for both).</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:9.08%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;">&nbsp;</p></td>
<td valign="top" style="width:3.85%;white-space:nowrap">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-family:'Symbol';font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#183;</p></td>
<td valign="top">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">As seen in the KP201.A03 trial, ease of insufflation scores suggest that KP201/APAP is more difficult to snort than IN Norco<sup style="font-size:85%; vertical-align:top">&#174;</sup>,<sup style="font-size:85%; vertical-align:top"> </sup>indicating that both KP201 by itself and KP201/APAP are likely difficult to &#8220;snort.&#8221;</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>

<hr style="page-break-after:always;width:100%;">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU3"></a><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In summary, data from the KP201.A02 intranasal human abuse liability trial confirm</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ed that KP201/APAP may be able to limit hydrocodone exposure as compared to Norco&#174; when both are administered intranasally.&nbsp;&nbsp;Liking scores were not significantly different, which KemPharm believes was potentially due to the effects of APAP. These results r</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">eaffirm the key properties of KP201/APAP that were observed in the prior oral human abuse liability trial (KP201.A01) and intranasal human abu</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">se liability trial (KP201.A03). </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">KemPharm plans to present the full human abuse liability data package as part of i</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ts New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to the U.S. Food and Drug Administration (FDA) as early as</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> by</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> the </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">end</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> of 2015.</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> </font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Post-NDA filing, KemPharm plans to conduct additional trials with</font><font style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> KP201 to further explore the overdose protective properties of KP201 at high oral doses as exhibited in the KP201.A01 oral human abuse liability trial.</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">This randomized, double-blind, double-dummy, placebo-controlled, single-dose, two-part, five-way crossover trial, with 46 subjects enrolled and 42 subjects completed, was designed to determine the exposure, abuse potential, and safety of equivalent doses of both crushed IN and intact (oral) KP201/APAP as compared to both crushed IN and intact (oral) Norco&#174; in opioid-experienced, non-dependent subjects. KP201/APAP demonstrated a lower Cmax, and a delay in Tmax, as well as a decrease in exposure to hydrocodone (AUC0-2h), especially in the early time points typically associated with an increased safety risk.&nbsp;&nbsp;Liking data for all treatments were similar, which KemPharm believes was potentially due to the effects of APAP.&nbsp;&nbsp;KP201, both with and without APAP, showed a high difficulty of snorting in both KP201.A02 and KP201.A03 trials even though both were administered as a fine powder.&nbsp;&nbsp;Adverse events were similar across all treatments.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:5.24%;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="S93736528"></a>Caution Concerning Forward Looking Statements</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:6.85%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Securities Exchange Act of 1934, as amended.&nbsp;&nbsp;Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as &#8220;may,&#8221; &#8220;will,&#8221; &#8220;expect,&#8221; &#8220;project,&#8221; &#8220;estimate,&#8221; &#8220;anticipate,&#8221; &#8220;plan,&#8221; &#8220;believe,&#8221; &#8220;potential,&#8221; &#8220;should,&#8221; &#8220;continue&#8221; or the negative versions of those words or other comparable words. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans.&nbsp;&nbsp;Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm&#8217;s business are described in additional detail in KemPharm's Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and KemPharm's other Periodic and Current Reports filed with the Securities and Exchange Commission.&nbsp;&nbsp;KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 9.01<font style="margin-left:54pt;">Financial Statements</font> and Exhibits.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div align="left">
<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top" style="width:5.77%;white-space:nowrap">
<p style="margin-bottom:0pt;margin-top:0pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(d)</p></td>
<td valign="top">
<p style="margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Exhibits</p></td></tr></table></div>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<div>
<table border="0" cellspacing="0" cellpadding="0" align="center" style="border-collapse:collapse; width:100%;">
<tr>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:10.58%; border-bottom:solid 0.75pt #000000;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Exhibit No.</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;width:1.92%; border-bottom:solid 0.75pt transparent;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:87.5%; border-bottom:solid 0.75pt #000000;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Description</p></td>
</tr>
<tr>
<td valign="top"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:10.58%; border-top:solid 0.75pt #000000;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">99.1</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:1.92%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p></td>
<td valign="top"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:87.5%; border-top:solid 0.75pt #000000;">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="OLE_LINK7"></a><a name="OLE_LINK8"></a>Press Release titled &#8220;KemPharm, Inc. Completes Human Abuse Liability Program for KP201/APAP&#8221; dated October 21, 2015.</p>
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
</tr>
</table></div>
<p style="margin-bottom:0pt;margin-top:9pt;text-indent:7.69%;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>

<hr style="page-break-after:always;width:100%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU4"></a><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES</font></p>
<p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:7.69%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&nbsp;</p>
<div>
<table border="0" cellspacing="0" cellpadding="0" align="center" style="border-collapse:collapse; width:100%;">
<tr>
<td valign="top"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:5%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td colspan="2" valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:49%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">K</font><font style="Background-color:#FFFFFF;font-size:7.5pt;">EM</font><font style="Background-color:#FFFFFF;">P</font><font style="Background-color:#FFFFFF;font-size:7.5pt;">HARM</font><font style="Background-color:#FFFFFF;">, I</font><font style="Background-color:#FFFFFF;font-size:7.5pt;">NC</font><font style="Background-color:#FFFFFF;">.</font></p></td>
</tr>
<tr>
<td valign="middle"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:5%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:3%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
</tr>
<tr>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;width:45%; border-bottom:solid 0.75pt transparent;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Date: October 21, 2015</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;width:5%; border-bottom:solid 0.75pt transparent;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="top"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;width:3%; border-bottom:solid 0.75pt transparent;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">By:</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%; border-bottom:solid 0.75pt #000000;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">/s/ R. LaDuane Clifton</p></td>
</tr>
<tr>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:5%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="middle"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:3%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%; border-top:solid 0.75pt #000000;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">R. LaDuane Clifton</p></td>
</tr>
<tr>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:5%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:3%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:45%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">Chief Financial Officer</font></p></td>
</tr>
</table></div>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>

<hr style="page-break-after:always;width:100%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_Toc403726853"></a><a name="_AEIOULastRenderedPageBreakAEIOU5"></a><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Exhibit </font><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Index</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&nbsp;</p>
<div>
<table border="0" cellspacing="0" cellpadding="0" align="center" style="border-collapse:collapse; width:100%;">
<tr>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:10.58%; border-bottom:solid 0.75pt #000000;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Exhibit No.</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;width:1.92%; border-bottom:solid 0.75pt transparent;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:87.5%; border-bottom:solid 0.75pt #000000;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Description</p></td>
</tr>
<tr>
<td valign="top"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:10.58%; border-top:solid 0.75pt #000000;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">99.1</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p></td>
<td valign="bottom"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:1.92%;">
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p></td>
<td valign="top"  BGCOLOR="#FFFFFF" style="padding-left:0pt;padding-Right:0.75pt;padding-Top:0.75pt;padding-Bottom:0pt;width:87.5%; border-top:solid 0.75pt #000000;">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Press Release titled &#8220;KemPharm, Inc. Completes Human Abuse Liability Program for KP201/APAP&#8221;  dated October 21, 2015.</p></td>
</tr>
</table></div>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></body>
</html>
[{"type": "8-K", "sequence": "1", "filename": "kmph-8k_20151021.htm", "description": "8-K", "secsgml_size_bytes": 56750}]
{"company-data": {"conformed-name": "KEMPHARM, INC", "cik": "0001434647", "assigned-sic": "2834", "irs-number": "205894398", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-36913", "film-number": "151168297"}, "business-address": {"street1": "2656 CROSSPARK ROAD, SUITE 100", "city": "CORALVILLE", "state": "IA", "zip": "52241", "phone": "319-665-2575"}, "mail-address": {"street1": "2656 CROSSPARK ROAD, SUITE 100", "city": "CORALVILLE", "state": "IA", "zip": "52241"}, "former-company": {"former-conformed-name": "KEMPHARM INC", "date-changed": "20080507"}}
kmph-8k_20151021.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 21, 2015
KEMPHARM, INC.
(Exact name of Registrant as Specified in Its Charter)
Delaware
001-36913
20-5894398
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
2656 Crosspark Road, Suite 100
Coralville, IA
52241
(Address of Principal Executive Offices)
(Zip Code)
Registrant's Telephone Number, Including Area Code:
(319) 665-2575
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01
Regulation FD
Disclosure
.
On October 21
, 2015,
KemPharm, Inc., a Delaware corporation, or KemPharm, issued a press release regarding the items described in Item 8.01 below
.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in the press release furnished as Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of KemPharm's filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01
Other Events.
On October 21, 2015, KemPharm reported
top-line results from the KP201.A02 intranasal human abuse liability clinical trial
.
This trial was a phase 1 type clinical trial in 42 healthy, non-dependent recreational drug abusers, to determine the exposure, abuse potential, and safety of crushed intranasal (IN) KP201/APAP relative to crushed IN Norco® (hydrocodone bitartrate/APAP). To highlight:
·
IN KP201/APAP exhibited significant pharmacokinetic differences from IN Norco
®
due primarily to a significant increase in time to achieve peak exposure (T
max
)(p = 0.0001) and lower peak hydrocodone exposure (C
max
) for KP201/APAP (p = 0.0027).
·
IN KP201/APAP did not result in greater hydrocodone exposure and produced a similar pharmacokinetic profile compared to both KP201/APAP and Norco
®
taken orally.
·
Hydrocodone exposure through peak drug effect showed a statistically significant reduction for IN KP201/APAP vs. IN Norco
®
:
o
0-0.5 hour: 50.1% reduction (p = 0.0044);
o
0-1.0 hour: 29.1% reduction (p = 0.0005); and
o
0-2.0 hours: 14.9% reduction (p = 0.0003).
·
Based on this reduced exposure to hydrocodone, drug liking through peak effect (2.0 hours) was significantly lower for IN KP201/APAP vs. IN Norco
®
(p<0.0001).
·
Mean peak drug liking (E
max
) was lower for KP201/APAP, both IN (75.9) and oral (76.9), compared to that of Norco
®
(79.0, IN; 77.9, oral), though liking scores were statistically similar for all treatments, which KemPharm believes was potentially due to the effects of APAP.
·
Median peak drug liking was lowest for IN KP201/APAP (74) and highest for IN Norco
®
(80).
·
Time to peak drug liking IN KP201/APAP was delayed (1.8 hours) compared to IN Norco
®
(1.0 hour), and was similar based on similar pharmacokinetics, to KP201/APAP and Norco
®
taken orally (2.0 hours for both).
·
As seen in the KP201.A03 trial, ease of insufflation scores suggest that KP201/APAP is more difficult to snort than IN Norco
®
,
indicating that both KP201 by itself and KP201/APAP are likely difficult to "snort."
In summary, data from the KP201.A02 intranasal human abuse liability trial confirm
ed that KP201/APAP may be able to limit hydrocodone exposure as compared to Norco® when both are administered intranasally.  Liking scores were not significantly different, which KemPharm believes was potentially due to the effects of APAP. These results r
eaffirm the key properties of KP201/APAP that were observed in the prior oral human abuse liability trial (KP201.A01) and intranasal human abu
se liability trial (KP201.A03).
KemPharm plans to present the full human abuse liability data package as part of i
ts New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to the U.S. Food and Drug Administration (FDA) as early as
by
the
end
of 2015.
Post-NDA filing, KemPharm plans to conduct additional trials with
KP201 to further explore the overdose protective properties of KP201 at high oral doses as exhibited in the KP201.A01 oral human abuse liability trial.
This randomized, double-blind, double-dummy, placebo-controlled, single-dose, two-part, five-way crossover trial, with 46 subjects enrolled and 42 subjects completed, was designed to determine the exposure, abuse potential, and safety of equivalent doses of both crushed IN and intact (oral) KP201/APAP as compared to both crushed IN and intact (oral) Norco® in opioid-experienced, non-dependent subjects. KP201/APAP demonstrated a lower Cmax, and a delay in Tmax, as well as a decrease in exposure to hydrocodone (AUC0-2h), especially in the early time points typically associated with an increased safety risk.  Liking data for all treatments were similar, which KemPharm believes was potentially due to the effects of APAP.  KP201, both with and without APAP, showed a high difficulty of snorting in both KP201.A02 and KP201.A03 trials even though both were administered as a fine powder.  Adverse events were similar across all treatments.
Caution Concerning Forward Looking Statements
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "should," "continue" or the negative versions of those words or other comparable words. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans.  Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm's business are described in additional detail in KemPharm's Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and KemPharm's other Periodic and Current Reports filed with the Securities and Exchange Commission.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01
Financial Statements
and Exhibits.
(d)
Exhibits
Exhibit No.
Description
99.1
Press Release titled "KemPharm, Inc. Completes Human Abuse Liability Program for KP201/APAP" dated October 21, 2015.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
K
EM
P
HARM
, I
NC
.
Date: October 21, 2015
By:
/s/ R. LaDuane Clifton
R. LaDuane Clifton
Chief Financial Officer
Exhibit
Index
Exhibit No.
Description
99.1
Press Release titled "KemPharm, Inc. Completes Human Abuse Liability Program for KP201/APAP"  dated October 21, 2015.