FDA approves Xartemis XR for management of Acute Pain - Mallinckrodt

Mallinckrodt plc announced that the FDA has on 11 March 2014 approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), 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 (e.g., non-opioid analgesics) are ineffective, not tolerated or would otherwise be inadequate.

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

Xartemis XR has both immediate- and extended-release components: formulated to provide onset of pain relief in less than one hour and to allow twice daily dosing. The product�s release profile combines Mallinckrodt�s newly patented technology, including design, formulation, pharmacokinetic and release characteristics, and Depomed�s advanced Acuform drug delivery technology.

The approval is based, in part, on the pivotal Phase III 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.