Egalet Corporation announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for August 4, 2016, to review the new drug application (NDA) for ARYMO™ ER (morphine sulfate) extended-release tablets, an abuse-deterrent, oral morphine product candidate. 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 FDA accepted the NDA in February for ARYMO ER which was developed using Egalet's proprietary abuse-deterrent Guardian™ Technology. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.
The regulatory submission includes a comprehensive battery of Category 1, 2 and 3 abuse-deterrent studies which were all conducted in accordance 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.
Egalet's proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel manufacturing process, plastic injection molding, which results in tablets with controlled-release properties as well as physical and chemical features that have been demonstrated to resist both common and rigorous methods of manipulation.
