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).
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.