FDA to Review NDA for New Extended-Release Morphine

FDA to Review NDA for New Extended-Release Morphine
FDA to Review NDA for New Extended-Release Morphine

Egalet announced that it has submitted to the Food and Drug Administration (FDA) a New Drug Application (NDA) for Arymo ER (morphine sulfate).

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The NDA submission is based on pharmacokinetic studies that demonstrated bioequivalence of Arymo ER 15mg, 30mg, and 60mg tablets to equivalent doses of MS Contin (morphine sulfate controlled-release). The company also submitted abuse-deterrent studies (Category 1, 2, 3). These demonstrated Arymo ER's properties resistance to methods of manipulation—including intravenous injection, snorting and oral abuse.

Morphine sulfate is a Schedule II opioid agonist.

For more information call (610) 833-4200 or visit Egalet.com.

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