Briefing Summary: US FDA Posts Advisory Committee Materials for Purdue’s Avridi, Proposed Abuse-Deterrent, Immediate-Release Oxycodone – SEP 10, 2015 (AADPAC-DSRM)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, September 10, 2015 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM). The Committees will discuss a New Drug Application (NDA) for Purdue Pharma’s oxycodone immediate-release tablets for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. The discussion will focus on two topics. The first is a safety issue related to decreased absorption when the drug is taken with food. The second is the adequacy of the product’s abuse-deterrent properties.
From 9:30 a.m. to 5 p.m., the meeting will be 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.