Background Analysis: US FDA Advisory Committee to Review the Impact of Oxycontin ER’s Abuse-Deterrent Formulation on Abuse – JUL 7–8, 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 (DSRM) Advisory Committee for Tuesday and Wednesday, July 7-8, 2015. The Committees will discuss the results of postmarketing studies evaluating the misuse and/or abuse of reformulated Oxycontin (oxycodone hydrochloride) extended-release (ER) tablets, supplemental new drug application (sNDA) 022272, manufactured by Purdue Pharma L. (Purdue). The Committees will discuss whether these studies have demonstrated that the reformulated Oxycontin product has had a meaningful impact on abuse of Oxycontin.