Apadaz benzhydrocodone/acetaminophen regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Risk Management advisory committees voted 16-4 that the agency should approve Apadaz benzhydrocodone/acetaminophen from KemPharm for the short-term management of acute pain but 18-2 that the treatment should not be labeled as an abuse-deterrent product. The PDUFA date is June 9. Apadaz is an abuse-deterrent, immediate-release, fixed-dose combination of benzhydrocodone, a prodrug of hydrocodone and benzoic acid, and acetaminophen. ...