News Feature | March 25, 2014

FDA Approves Mallinckrodt's Xartemis For Pain

By Cyndi Root

Mallinckrodt Pharmaceuticals announced via press release that the Food and Drug Administration (FDA) has approved Xartemis XR. The oxycodone hydrochloride and acetaminophen combination, available in extended release tablets, is formerly known as MNK-795. The oral formulation is the first combination of the two pain medications in extended-release form. Mark Trudeau, President and Chief Executive Officer of Mallinckrodt, said, “We will continue to work closely with the FDA as we engage in further development programs for Xartemis XR and other products utilizing this technology platform.”

Acute Pain

Acute severe pain occurs due to traumatic injury or surgery, among other reasons. Pain management is important to improve the patient’s quality of life and to alleviate the cost to business due to lost productivity. According to the Institute of Medicine, in the U.S., over 150 million inpatient and outpatient surgical procedures are performed each year. About 80% of patients have pain after the procedure, and many experience severe or extreme pain. Many patients have acute and severe pain that warrants opioid treatment. Nathaniel Katz, MD, MS, Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine, said, “Acute pain doesn’t last for only four to six hours, and neither should its treatment. “


Xartemis is formulated with oxycodone and acetaminophen, with components that deliver the drug in immediate-release and extended-release. Oxycodone and acetaminophen are clinically proven pain medications combined together for a distinctive pharmokinetic profile. Oxycodone is an opioid and acetaminophen (paracetemol) is a mild analgesic. The combination of the drugs in Xartemis is indicated for severe pain when other treatments are inadequate. Xartemis is a schedule II controlled substance and like any opioid, the drug carries risks for abuse, addiction, overdose, and death.

Xartemis Clinical Trials

Phase 3 clinical trials helped show efficacy and led to the FDA’s approval. Patients with acute pain after surgery found pain relief with Xartemis, with improvements in pain measures during the first 48 hours of treatment. Mallinckrodt also conducted abuse studies, lab testing, and presented evidence from the studies at scientific conferences. The company is still working with the FDA to define attributes of the drug, like the delivery method, that would help prevent abuse of the powerful pain reliever. The FDA may require further studies on safety, efficacy, and abuse deterrence.