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Egalet U.S. ARYMO PDUFA

10/14/2016 - 00:00

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Egalet Announces FDA Acceptance of New Drug Application for ARYMO™ ER (Morphine Sulfate) Extended-Release Tablets

Feb 29, 2016

WAYNE, Pa., Feb. 29, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced that the U.S. Food and Drug Administration (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.

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"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 2015 U.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.

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Source: press release, 2/29/16. http://egalet.investorroom.com/2016-02-29-Egalet-Announces-FDA-Acceptanc...

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