Background Analysis: US FDA Advisory Committees to Review Teva’s Proposed Extended-Release Opioid with Abuse-Deterrent Properties – JUN 7, 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 Tuesday, June 7, 2016. The Committees will discuss a new drug application (NDA 207975) for hydrocodone bitartrate extended-release (ER) tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., (Teva) 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. The product is an ER formulation intended to have abuse-deterrent properties based on its physicochemical properties. The Committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

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.

See the SAC Tracker report