KemPharm has announced that its Investigational New Drug application for KP201/IR has been granted “Fast Track” designation 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 initiate human clinical trials of KP201/IR in the first half of 2017.
“We are very pleased that the FDA has granted KP201/IR ‘Fast Track’ designation. This designation will help expedite the development and review of KP201/IR and provides us with the opportunity to have more frequent interactions with the Agency and a potential ‘rolling review’ of our application prior to submission of the complete New Drug Application (NDA) for KP201/IR,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “As previously announced, 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 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.