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FDA approves Egalet's Arymo

January 10, 2017 12:30 AM UTC

FDA approved Arymo ER morphine sulfate extended-release from Egalet Corp. (NASDAQ:EGLT) to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The company expects to launch the drug this quarter.

In August, FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 18-1 to recommend Arymo's approval. It is an oral extended release formulation of morphine sulfate that uses Egalet's Guardian abuse-deterrent technology (see BioCentury Extra, Aug. 4, 2016). ...

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