Mallinckrodt: FDA Approves XARTEMIS XR Extended-Release Tablets

(RTTNews) - Mallinckrodt plc (MNK) announced the U.S. FDA has approved XARTEMIS XR Extended-Release Tablets, previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options are ineffective, not tolerated or would otherwise be inadequate. The approval is based, in part, on the pivotal Phase 3 efficacy study conducted in an acute post-surgical pain model. XARTEMIS XR met the study's primary endpoint and showed statistically significant improvement in pain scores compared to placebo from baseline over 48 hours.

Mallinckrodt noted that XARTEMIS XR is the first and only extended-release oral combination of two clinically proven pain medications -- oxycodone and acetaminophen.