Mallinckrodt receives FDA approval for Xartemis XR

DUBLIN — Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.



The drug also is indicated for patients for whom alternative treatments have shown to be ineffective. Xartemis XR, previously known as MNK-795, is the first and only extended-release oral combination of two clinically proven pain medications — oxycodone and acetaminophen.



Pain that is left uncontrolled or unmanaged results in significant costs to U.S. business in terms of lost productivity, according to the company. Data from the Institute of Medicine showed that in 2011, 80% of patients undergoing surgery experienced postoperative pain. Eighty-eight percent reported the pain to be 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, MD, MS, 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.”