KemPharm (KMPH) Files IND with U.S. FDA to Commence Human Trials of KP201/IR

October 25, 2016 7:41 AM EDT
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KemPharm, Inc. (Nasdaq: KMPH) announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin human clinical trials of KP201/IR, the Company’s immediate release (IR) abuse-deterrent hydrocodone product candidate with an acetaminophen (APAP)-free formulation.

“The filing of the IND for KP201/IR, combined with our recent announcement to utilize Acura Pharmaceuticals’ FDA-approved Aversion® Technology with KP201/IR, are key steps in the advancement of our IR abuse-deterrent opioid prodrug pipeline,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “With this filing, we intend to initiate human clinical trials of KP201/IR in the first half of 2017 and remain on target for a potential submission in 2018 of the KP201/IR New Drug Application (NDA).”

Dr. Mickle continued, “Today’s news, along with the recent acceptance of the IND for KP415, our extended release (ER) d-threo-methylphenidate (d-MPH) product candidate for the treatment of attention deficit hyperactivity disorder (ADHD), means that our two lead product candidates are meeting the early regulatory milestones we have established for them.”

KP201/IR has the potential to reach the market as the first abuse-deterrent IR hydrocodone product, as well as the first IR hydrocodone-related product without acetaminophen. KemPharm believes KP201/IR is well-positioned to take advantage of data generated from the Apadaz™ development program, including data from the KP201.A03 study, which compared hydrocodone exposure following insufflation of benzhydrocodone HCl (KP201) vs. hydrocodone bitartrate (HB). KemPharm believes that the data observed in the A03 study, if replicated in a full human abuse potential study, aligns with the FDA Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) criteria for achieving abuse-deterrent product labeling, and could potentially provide KP201/IR with a favorable regulatory pathway.



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