Background Analysis: US FDA Advisory Committees to Review Pfizer’s Proposed Extended-Release Opioid with Abuse-Deterrent Properties – JUN 8, 2016 (AADPAC-DSRM)

The US FDA has scheduled a joint meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees (AADPAC-DSRM) for Wednesday, June 8, 2016. The Committees will discuss Pfizer's NDA 207621 for oxycodone hydrochloride and naltrexone hydrochloride extended-release 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.

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