FDA Committees Recommend Approval of Arymo ER
Egalet announced that the Food and Drug Administration (FDA)'s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-1 to recommend approval of Arymo ER (morphine sulfate) tablets 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.
At the joint meeting, the Committees also voted that if approved, Arymo ER should be labeled as an abuse-deterrent product by the oral route of abuse (16-3), by the nasal route of abuse (18-1), and by the intravenous route of abuse (18-1). The labeling for Arymo ER, if approved, will include the drug's abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated.
Morphine sulfate, an opioid agonist, is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of morphine sulfate is analgesia. Other therapeutic effects include anxiolysis, euphoria, and feelings of relaxation. Morphine sulfate and related opioids also depress the cough reflex by direct effect on the cough center in the medulla.
The FDA will consider the Committees' guidance during the New Drug Application (NDA) review for Arymo ER. The FDA Prescription Drug User Fee Act (PDUFA) date for a decision is anticipated for October 14, 2016.
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