The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, August 4, 2016 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM). The Committee will discuss new drug application (NDA) 208603 for Arymo ER (morphine sulfate extended-release tablets), submitted by Egalet US, Inc. (Egalet), with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It has been formulated with the intent to provide abuse-deterrent properties. The Committees will be asked to discuss whether the data submitted by the sponsor are sufficient to support labeling of the product with the properties expected to deter abuse.
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.
See the SAC Tracker report