The US FDA has scheduled a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) for Thursday, August 4, 2016. The Committees 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.
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