The first FDA approved long-acting combination of narcotic analgesic oxycodone with acetaminophen is now available for pain management. It will be manufactured by Mallinckrodt and is a single strength tablet to be dosed twice daily. This new form of pain medicine is sold under the name Xartemis XR, and will treat patients with severe pain who don’t respond to alternate therapies. Xartemis XR should not be used with other medicines that contain acetaminophen, nor should it be used in place of other oxycodone/acetaminophen products. Mallinckrodt is looking to provide more abuse-deterrent features for the FDA, as Xartemis does not currently have them.
“The FDA approval of Xartemis XR exemplifies Mallinckrodt’s dedication to developing and providing new treatment options for people with pain,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. “Mallinckrodt remains committed to continuing its work to develop innovative formulations for our product lines to help ensure access to appropriate pain treatment for the millions of patients suffering from acute pain, and 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.”