FDA to Review Extended Release Morphine Sulfate Tablets
Arymo ER treats patients with severe pain who need long-term relief and have inadequate responses to alternative treatment options.
The FDA has accepted Egalet Corporation’s new drug application for morphine sulfate extended-release tablets (Arymo ER).
The tablets are designed to treat patients who have severe pain; need daily, long-term relief; and have inadequate responses to alternative treatment options.
The FDA’s goal date for a decision on the application is October 14, 2016.
The submission was based on data from pharmacokinetic studies that demonstrated bioequivalence of Arymo ER 15 mg, 30 mg, and 60 mg to equivalent doses of MS Contin.
"The acceptance of our new drug application for Arymo ER marks an important and exciting step toward the approval of our first Guardian Technology product candidate," said Jeffrey Dayno, MD, chief medical officer of Egalet, in a press release. "We look forward to working with the FDA during the review process in order to bring this product to market as quickly as possible."
The FDA has stated that it intends to hold an advisory committee meeting to discuss the application from Egalet.