Panel backs KemPharm analgesic, doubts abuse deterrence

FDA's Anesthetic and Analgesic Drug Products and Risk Management Advisory Committees voted 16-4 that the agency should approve Apadaz benzhydrocodone/acetaminophen ( KP201/APAP) from KemPharm Inc. (NASDAQ:KMPH) for the short-term management of acute pain, but 18-2 that the treatment should not be labeled as an abuse-deterrent product.

Committee members said KemPharm did not sufficiently demonstrate Apadaz's abuse deterrent properties, saying that deterrence studies were conducted under best-case scenarios and the company did not adequately address the potential for users to extract the candidate's active ingredient using solvents. According to KemPharm, Apadaz is converted into an active form in the gastrointestinal tract, reducing the risk of its abuse through nasal or intravenous administration. ...