The US FDA has posted materials, including FDA and company briefing documents, for a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee for Thursday, May 5, 2016.
The Committees will discuss a new drug application (NDA 208653) for benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc. (KemPharm). The proposed indication is short-term (up to 14 days) management of acute pain. The product is formulated with the intent to provide abuse-deterrent properties.
From 8:00 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the Committees will discuss the drug development program of an investigational abuse-deterrent opioid product.
See the SAC Tracker report