FDA Advisory Committee recommends Arymo ER (morphine sulfate) for treatment of severe pain.- Egalet Corporation

Egalet Corporation announced that the joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 18 to 1 to recommend approval of Arymo ER (morphine sulfate). Arymo ER was developed using Egalet's proprietary Guardian Technology for 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 Committee also voted: �16 to 3 that if approved, Arymo ER should be labeled as an abuse-deterrent product by the oral route of abuse; �18 to 1 that if approved, Arymo ER should be labeled as an abuse-deterrent product by the nasal route of abuse; and �18 to 1 that if approved, Arymo ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.

Based on the committees' votes, Egalet anticipates, if approved, the label for Arymo ER will describe the product's abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the NDA for Arymo ER. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.