Mallinckrodt plc has received approval from the Food and Drug Administration for Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), an opioid pain reliever.

Mallinckrodt, Xartemis XR, oxycodone and acetaminophen, opioid pain reliever, management of acute pain, opioid treatment, Mark Trudeau, Nathaniel Katz, Tufts University School of Medicine, Food and Drug Administration, FDA

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Mallinckrodt's Xartemis XR combo painkiller OK'd by FDA

March 13th, 2014

DUBLIN, Ireland – Mallinckrodt plc has received approval from the Food and Drug Administration for Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), an opioid pain reliever.

The company said Wednesday that Xartemis XR is the first and only extended-release oral combination of two clinically proven pain medications, oxycodone and acetaminophen.

According to Mallinckrodt, the medication is indicated for the management of acute pain that's severe enough to require opioid treatment and in patients for whom alternative treatment options — such as non-opioid analgesics — are ineffective, not tolerated or would otherwise be inadequate.

Xartemis XR has immediate- and extended-release components, as it is formulated to provide onset of pain relief in less than one hour and to allow twice daily dosing, Mallinckrodt noted. 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.

"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," Nathaniel Katz, M.D., adjunct assistant professor of anesthesia at Tufts University School of Medicine, said in a statement. "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."

Pain that is uncontrolled or unmanaged results in ongoing and very significant costs to U.S. businesses in terms of lost productivity, according to Mallinckrodt. The company reported that in 2010, there were over 102 million surgical procedures ordered or performed at office visits and, 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 and, of those, 88% said the pain was moderate, severe or extreme.

Mallinckrodt noted that it conducted extensive lab testing and a human abuse liability study with Xartemis XR. Though the approved label for the product doesn't include abuse-deterrent language, Mallinckrodt said it 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 added that it's conducting additional studies and will be providing additional data in the near future.

"The FDA approval of Xartemis XR exemplifies Mallinckrodt's dedication to developing and providing new treatment options for people with pain," stated 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."

To address the problems of opioid misuse and abuse, Mallinckrodt said it supports a wide range of programs that encourage and support only proper use of pain medications, and the company addresses diversion and abuse through a multidimensional approach that includes educational efforts, monitoring for suspicious orders of controlled substances, drug take-back programs and research into abuse-deterrent technologies.