Background Analysis: US FDA Joint Advisory Committee to Weigh in On the Return of Perdue’s Oxycodone IR With an Abuse-Deterrent Formulation– SEP 10, 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 Advisory Committee (DSRM) meeting for Thursday, September 10, 2015. 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.