Egalet Reveals FDA Advisory Committee Meeting for ARYMO ER Extended-Release Tablets

Egalet Corporation

revealed Tuesday that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA has been convened for August 4. The meeting would review the new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets, an abuse-deterrent, oral morphine product candidate. Egalet said that ARYMO ER was 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. The company said that the medical regulator accepted the NDA in February for ARYMO ER and that it was developed with its proprietary abuse-deterrent Guardian Technology. The company added that the FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14. The regulatory submission included a complete battery of Category 1, 2 and 3 abuse-deterrent studies that were all conducted in line with the FDA Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling to support abuse-deterrent label claims for ARYMO ER regarding intravenous injection, snorting and oral routes of misuse and abuse. On Tuesday, shares of the company gained 2.71 percent.