AUG 4 AADPAC-DSRM

On Thursday, August 4, 2016, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM). supported, by a vote of 18-Yes to 1-No, with no abstentions, the safety and efficacy of Arymo ER (morphine sulfate extended-release tablets), submitted by Egalet US, Inc. (Egalet), for 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. The Committees also voted that the data submitted by Egalet are sufficient to support labeling of the product as having properties expected to deter abuse.

See the SAC Tracker report