KemPharm, Inc. announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for May 5, 2016, to review KemPharm’s New Drug Application (NDA) for KP201/APAP, its lead investigational drug candidate for the short-term management of acute pain.
KP201/APAP is a combination of KP201, KemPharm's prodrug of hydrocodone (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is being developed as an abuse-deterrent immediate release prodrug of hydrocodone bitartrate/APAP.
The Company’s NDA for KP201/APAP was accepted and granted priority review by the FDA in early February 2016. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
