The US Food and Drug Administration (FDA) has extended the review of Mallinckrodt's New Drug Application (NDA) for investigational compound Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release tablets (CII). Xartemis XR, previously known as MNK-795, was studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
The three-month extension from the FDA is in response to additional data submitted by Mallinckrodt. Mallinckrodt and the FDA have begun and will continue discussions regarding labeling as part of the application review throughout this period.
“If approved, we believe that Xartemis XR could provide an important new option as an extended-release treatment for patients with acute pain,” said Mark Trudeau, president and CEO, Mallinckrodt. “As a leader in pain management, Mallinckrodt remains committed to developing medications that address the needs of patients, and will work with the FDA throughout the review of the Xartemis XR application.”
Xartemis XR, an investigational, extended-release oral formulation of oxycodone and acetaminophen uses a dual layer delivery mechanism with both immediate- and extended-release components. In July, the FDA accepted for filing the NDA for Xartemis XR and granted priority review. There are currently no extended-release oxycodone/acetaminophen combinations on the market for the management of acute pain.
Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents.