Background Analysis: US FDA Advisory Committee to Review Collegium’s Xtampza ER, a Proposed Abuse Deterrent, Extended-Release Oxycodone Product – SEP 11, 2015 (AADPAC-DSRM)
The US FDA has scheduled a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Committee (DSRM) for Friday, September 11, 2015. The Committees will jointly discuss a New Drug Application (NDA) for Collegium Pharmaceutical Inc.’s oxycodone extended-release capsules, proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. The products have been formulated with the intent to provide abuse-deterrent properties.
From 9:30 a.m. to 5 p.m., the meeting is open to the public. From 8 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 product.