KemPharm's (KMPH) IND for KP201/IR Accepted by U.S. FDA

November 29, 2016 7:33 AM EST
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KemPharm, Inc. (Nasdaq: KMPH) announced that its Investigational New Drug (IND) application for KP201/IR has been accepted by the U.S. Food and Drug Administration (FDA). KP201/IR, KemPharm’s co-lead product candidate, is a single-entity benzhydrocodone HCl immediate release abuse-deterrent prodrug for the treatment of acute pain. KemPharm expects to conduct human clinical trials of KP201/IR in 2017.

“We are very pleased that the FDA has accepted our IND request for KP201/IR. This, along with the recent acceptance of the IND and initiation of human clinical trials for KP415, our extended release d-threo-methylphenidate 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,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “With this clearance, 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).”

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 (APAP). 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. KemPharm believes that the data observed in the KP201.A03 study, if replicated in a full human abuse potential study, may align with the FDA Division of Anesthesia, Analgesia, and Addiction Products criteria for achieving abuse-deterrent product labeling.

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