FDA panels back Egalet's Arymo

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. ...