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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:4pt;">&nbsp;</p>
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<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>
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<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): September 30, 2015</p>
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<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>
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<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>
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<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>
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<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>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:12pt;">&nbsp;</p></td>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<p style="margin-bottom:0pt;margin-top:6pt;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="text-align:justify;margin-bottom:0pt;margin-top:6pt;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 September 30, 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>.<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="margin-bottom:0pt;margin-top:6pt;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="text-align:justify;margin-bottom:0pt;margin-top:6pt;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 September 30, 2015, KemPharm announced<font style="color:#000000;"> </font>positive results from three distinct studies designed to evaluate the tamper-resistant properties of its lead opioid prodrug KP201/APAP, KemPharm&#8217;s prodrug of hydrocodone in combination with acetaminophen, or APAP, compared to a generic hydrocodone bitartrate/APAP product, or HB/APAP.  The highlights from these tampering studies included:</p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Under all conditions tested (over 1,000 conditions examined), the amount of hydrocodone released from KP201, the active pharmaceutical ingredient, or API, of KP201/APAP, was less than the amount of hydrocodone released from HB/APAP tablets.</p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Extraction of KP201 yielded mostly inactive KP201, while hydrocodone was efficiently extracted from HB/APAP under the same conditions.</p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Greater than 90% of all conditions tested for extraction yielded no hydrocodone released from KP201.</p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Conditions that led to any release of hydrocodone from KP201/APAP required harsh chemicals and usually heat; by comparison, hydrocodone was extracted from HB/APAP tablets with only water.</p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Traditional means of preparing a drug for injection were not suitable for KP201/APAP, yielding only inactive KP201, while up to 100% of hydrocodone could be extracted from HB/APAP tablets by the same process.</p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#8226;</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Cold water extraction yielded no free hydrocodone from KP201/APAP.</p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Smoking or freebasing of KP201/APAP tablets was not possible.</p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#8226;</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Smoking of the KP201 API itself after extraction yielded no hydrocodone; by comparison, it was possible to smoke the hydrocodone API.</p></td></tr></table></div>
<p style="text-align:justify;margin-top:6pt;margin-bottom:0pt;text-indent:4.81%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The first study, KP201.T01, evaluated KP201/APAP for the possibility and potential for individuals to extract the KP201 prodrug from its tablet formulation and convert the extracted KP201 API into active hydrocodone, following a protocol that KemPharm developed with input from the United Stated Food and Drug Administration, or the FDA. The study evaluated how the abuse-deterrent properties of KP201 could be defeated or compromised, as compared to HB/APAP tablets. The results showed that efforts to extract and hydrolyze KP201/APAP were less efficient compared to HB/APAP tablets.&nbsp;&nbsp;Under the more than 1,000 conditions tested, KP201/APAP released less hydrocodone compared to the hydrocodone released from the HB/APAP tablets in every case, usually only yielding the inactive prodrug, KP201.</p>
<p style="text-align:justify;margin-top:6pt;margin-bottom:0pt;text-indent:4.81%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">A second study, KP201.T02, was designed to determine the properties of KP201 that reduce the likelihood of intravenous, or IV, abuse of KP201/APAP as compared to HB/APAP, based again on a protocol developed by KemPharm with input from the FDA. The study evaluated the amount of KP201, APAP and hydrocodone detected in an extract derived from KP201/APAP tablets that would be suitable for IV abuse.&nbsp;&nbsp;The results showed the traditional means used to prepare a drug for injection were likely not suitable for KP201/APAP.&nbsp;&nbsp;In each condition employed, only inactive KP201 was extracted, if anything at all, while up to 100% of the hydrocodone from HB/APAP tablets could be extracted for injection.&nbsp;&nbsp;Cold water extraction methods typically used to &#8220;enrich&#8221; or &#8220;purify&#8221; the hydrocodone from HB/APAP also yielded only inactive KP201 with zero release of hydrocodone from the prodrug.&nbsp;&nbsp;As expected, hydrocodone was readily extracted from HB/APAP tablets by this method.</p>
<p style="text-align:justify;margin-top:6pt;margin-bottom:0pt;text-indent:4.81%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The final study, KP201.T03, examined the potential to abuse KP201/APAP by smoking.&nbsp;&nbsp;The results demonstrated that KP201/APAP could not be smoked in either tablet or API form.&nbsp;&nbsp;The results also showed that freebasing KP201/APAP was not possible.&nbsp;&nbsp;By contrast, HB/APAP can be prepared as a freebase and also smoked as the API.</p>
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<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 and Exhibits.</font></p>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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 Reports Positive Data Demonstrating Tamper-Resistant Properties of KP201/APAP&#8221; dated September 30, 2015.</p>
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<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>

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<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;"><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>
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<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>
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<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>
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<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>
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<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: September 30, 2015</p></td>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>

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<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><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>
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<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>
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<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>
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kmph-8k_20150930.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): September 30, 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 September 30, 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 September 30, 2015, KemPharm announced
positive results from three distinct studies designed to evaluate the tamper-resistant properties of its lead opioid prodrug KP201/APAP, KemPharm's prodrug of hydrocodone in combination with acetaminophen, or APAP, compared to a generic hydrocodone bitartrate/APAP product, or HB/APAP.  The highlights from these tampering studies included:
•
Under all conditions tested (over 1,000 conditions examined), the amount of hydrocodone released from KP201, the active pharmaceutical ingredient, or API, of KP201/APAP, was less than the amount of hydrocodone released from HB/APAP tablets.
•
Extraction of KP201 yielded mostly inactive KP201, while hydrocodone was efficiently extracted from HB/APAP under the same conditions.
•
Greater than 90% of all conditions tested for extraction yielded no hydrocodone released from KP201.
•
Conditions that led to any release of hydrocodone from KP201/APAP required harsh chemicals and usually heat; by comparison, hydrocodone was extracted from HB/APAP tablets with only water.
•
Traditional means of preparing a drug for injection were not suitable for KP201/APAP, yielding only inactive KP201, while up to 100% of hydrocodone could be extracted from HB/APAP tablets by the same process.
•
Cold water extraction yielded no free hydrocodone from KP201/APAP.
•
Smoking or freebasing of KP201/APAP tablets was not possible.
•
Smoking of the KP201 API itself after extraction yielded no hydrocodone; by comparison, it was possible to smoke the hydrocodone API.
The first study, KP201.T01, evaluated KP201/APAP for the possibility and potential for individuals to extract the KP201 prodrug from its tablet formulation and convert the extracted KP201 API into active hydrocodone, following a protocol that KemPharm developed with input from the United Stated Food and Drug Administration, or the FDA. The study evaluated how the abuse-deterrent properties of KP201 could be defeated or compromised, as compared to HB/APAP tablets. The results showed that efforts to extract and hydrolyze KP201/APAP were less efficient compared to HB/APAP tablets.  Under the more than 1,000 conditions tested, KP201/APAP released less hydrocodone compared to the hydrocodone released from the HB/APAP tablets in every case, usually only yielding the inactive prodrug, KP201.
A second study, KP201.T02, was designed to determine the properties of KP201 that reduce the likelihood of intravenous, or IV, abuse of KP201/APAP as compared to HB/APAP, based again on a protocol developed by KemPharm with input from the FDA. The study evaluated the amount of KP201, APAP and hydrocodone detected in an extract derived from KP201/APAP tablets that would be suitable for IV abuse.  The results showed the traditional means used to prepare a drug for injection were likely not suitable for KP201/APAP.  In each condition employed, only inactive KP201 was extracted, if anything at all, while up to 100% of the hydrocodone from HB/APAP tablets could be extracted for injection.  Cold water extraction methods typically used to "enrich" or "purify" the hydrocodone from HB/APAP also yielded only inactive KP201 with zero release of hydrocodone from the prodrug.  As expected, hydrocodone was readily extracted from HB/APAP tablets by this method.
The final study, KP201.T03, examined the potential to abuse KP201/APAP by smoking.  The results demonstrated that KP201/APAP could not be smoked in either tablet or API form.  The results also showed that freebasing KP201/APAP was not possible.  By contrast, HB/APAP can be prepared as a freebase and also smoked as the API.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
Exhibit No.
Description
99.1
Press Release titled "KemPharm Reports Positive Data Demonstrating Tamper-Resistant Properties of KP201/APAP" dated September 30, 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: September 30, 2015
By:
/s/ R. LaDuane Clifton
R. LaDuane Clifton
Chief Financial Officer
Exhibit
Index
Exhibit No.
Description
99.1
Press Release titled "KemPharm Reports Positive Data Demonstrating Tamper-Resistant Properties of KP201/APAP" dated September 30, 2015.