Egalet announces FDA acceptance of new drug application for ARYMO™ ER (morphine sulfate) extended-release tablets.
Egalet Corporation announced that the FDA has accepted the new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets.
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. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.
“The acceptance of our NDA for ARYMO ER marks an important and exciting step toward the approval of our first Guardian™ Technology product candidate,” said Jeffrey Dayno, MD, chief medical officer of Egalet. “We look forward to working with the FDA during the review process in order to bring this product to market as quickly as possible.”
The 505(b)(2) regulatory submission is based on pivotal pharmacokinetic studies that demonstrated bioequivalence of ARYMO ER 15 mg, 30 mg and 60 mg to equivalent doses of MS Contin (morphine sulfate controlled-release). In addition, the submission includes a comprehensive battery of Category 1, 2 and 3 abuse-deterrent studies which were all conducted in accordance with the April 2015U.S. Food and Drug Administration (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.
The FDA indicated that they currently plan to hold an advisory committee meeting to discuss the application.
Egalet’s Guardian Technology has many applications and has been used to develop commonly abused prescription medications in an abuse-deterrent form. Morphine sulfate is an opioid agonist and a Schedule II controlled substance with an acknowledged abuse liability. The risk of accidental misuse and abuse of morphine was the focus of the development program for ARYMO ER, which demonstrated physical and chemical features that are resistant to both common and more rigorous methods of manipulation. 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. Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient. In addition, the technology results in a viscous hydrogel on contact with liquid, making syringeability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation.