Mallinckrodt plc announced that the U.S. Food and Drug Administration (FDA) has 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 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.
In addition to the efficacy study, Mallinckrodt conducted extensive lab testing and a human abuse liability study with Xartemis XR. Data from Mallinckrodt’s studies related to the product were described in 15 scientific presentations at PAINWeek, held Sept. 4 to 7, 2013. While the approved label for Xartemis XR does not include abuse-deterrent language, Mallinckrodt will continue working closely with the FDA to develop more data to characterize abuse-deterrence features of Xartemis XR and other products utilizing this technology platform. The company is conducting additional studies and will be providing additional data in the near future.
Pain that is uncontrolled or unmanaged results in ongoing and very significant costs to U.S. businesses in terms of lost productivity. In 2010, there were over 102 million surgical procedures ordered or performed at office visits. That same year, there were 51 million inpatient surgeries performed. The Institute of Medicine reported in 2011 that 80% of patients undergoing surgery experience postoperative pain. Of these, 88% report the pain is moderate, severe or extreme.
“Acute pain doesn’t last for only four to six hours, and neither should its treatment. With the extended-release profile of Xartemis XR, patients may not need to wake in the night to take a dose,” said Nathaniel Katz, adjunct assistant professor of anesthesia at Tufts University School of Medicine. “A long-acting combination analgesic that can effectively deliver oxycodone and acetaminophen for acute pain patients experiencing pain throughout the day and night is a welcome addition to the treatment landscape.”
“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.”
Date: March 12, 2014