JUN 8 AADPAC-DSRM

The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, June 8, 2016 joint meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees (AADPAC-DSRM). The Committees will discuss Pfizer's NDA 207621 for Toxyca ER (oxycodone hydrochloride and naltrexone hydrochloride extended-release (ER) capsules), with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties.

From 8:00 a.m. to 9:30 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