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FDA panels back Egalet's Arymo

August 4, 2016 7:00 AM UTC

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 18-1 on Thursday to recommend approval of Arymo ER morphine sulfate extended-release from Egalet Corp. (NASDAQ:EGLT) to manage pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

The committees also voted 16-3 that Arymo ER should be labeled as abuse-deterrent by the oral route of abuse, 18-1 by the nasal route, and 18-1 by the IV route. ...