Egalet files NDA for Arymo ER with FDA

US biotech firm Egalet (Nasdaq: EGLT) saw its shares gain 5.6% to $10.33 by mid-morning, after it revealed it had filed a New Drug Application for Arymo ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

The submission to the US Food and Drug Administration is based on the pivotal pharmacokinetic studies that demonstrated bioequivalence of Arymo ER (formerly known as Egalet-001) 15mg, 30mg and 60mg 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.

"Given the need for treatment options for the millions of individuals living with chronic pain, combined with the importance of providing formulations that deter opioid abuse because of the prescription abuse epidemic here in the United States, the NDA submission of Arymo ER represents an important milestone and is the first NDA from our proprietary Guardian Technology program," said Bob Radie, president and chief executive of Egalet, adding: "We look forward to working with the FDA to bring to market Arymo ER for people living with chronic pain."