FDA Extends Review Of Mallinckrodt' NDA For Xartemis XR Extended-Release Tablets

(RTTNews) - Mallinckrodt (MNK) announced Monday that the U.S. Food and Drug Administration or FDA extended the review of the New Drug Application or NDA for investigational compound Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets or 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 Chief Executive Officer, Mallinckrodt.

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.