Egalet Says FDA Will Not Meet PDUFA Goal Data For ARYMO ER

(RTTNews) - Egalet Corp. (EGLT) announced that the U.S. Food and Drug Administration (FDA) will not meet the previously announced October 14 prescription drug user fee act (PDUFA) date for ARYMO™ ER (morphine sulfate).

On August 4, 2016 an FDA Advisory Committee voted 18 to 1 for approval of ARYMO ER and the Committee recommended ARYMO ER should be labeled as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse. ARYMO ER is being developed 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. If approved, ARYMO ER would be the first product developed using Egalet's proprietary Guardian™ Technology—a physical and chemical barrier approach to abuse-deterrence that results in tablets that are difficult to manipulate for the purpose of misuse and abuse.