Egalet files Arymo (morphine sulfate extended-release tablets) at FDA to treat severe pain
Egalet Corporation has announced the company has submitted a new drug application (NDA) for Arymo ER (morphine sulfate) extended-release tablets (formerly Egalet 001) for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.
The submission is based on the 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 abuse-deterrent studies (Category 1, 2 and 3) which were conducted to support abuse-deterrent label claims for intravenous injection, snorting and oral abuse.
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