FDA Accepts NDA for Controlled Opioid Agonist

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FDA Accepts NDA for Controlled Opioid Agonist
FDA Accepts NDA for Controlled Opioid Agonist

Egalet has announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Arymo ER (morphine sulfate) extended-release tablets 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 submission was supported by data from pharmacokinetic studies that demonstrated bioequivalence of Arymo ER 15mg, 30mg and 60mg to equivalent doses of MS Contin (morphine sulfate controlled-release). It also included Category 1, 2 and 3 abuse-deterrent studies to support the label claims for Arymo ER regarding its abuse-deterrent properties in intravenous injection, snorting, and oral routes of misuse and abuse.

The FDA plans to hold an advisory committee meeting to discuss the NDA application. It has set a Prescription Drug User Fee Act (PDUFA) goal date of October 14, 2016 to make a decision.

Arymo ER is an opioid agonist and a Schedule II controlled substance. It incorporates Egalet's Guardian Technology, a polymer matrix tablet technology, resulting in tablets with controlled-release properties as well as physical and chemical features that can resist both common and rigorous methods of manipulation.

For more information visit Egalet.com.

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