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Oxycodone/Acetaminophen Combo Gets FDA Nod

Xartemis XR has twice-daily dosing

The FDA has approved Xartemis XR (oxycodone hydrochloride and acetaminophen, Mallinckrodt) extended-release tablets (CII) for the management of acute pain severe enough to require opioid treatment and for patients in 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.

The FDA’s approval is partly based on data from a pivotal phase III 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 from baseline to more than 48 hours compared with placebo.

In addition to the pivotal efficacy study, Xartemis XR was evaluated in extensive lab testing and in a human abuse-liability study. Data from these studies were reported in scientific presentations at PAINWeek, held September 4–7, 2013 in Las Vegas, Nevada.

Pain that is uncontrolled or unmanaged results in significant costs to U.S. businesses in terms of lost productivity. In 2010, more than 102 million surgical procedures were ordered or performed at office visits. That same year, 51 million inpatient surgeries were performed. In 2011, the Institute of Medicine reported that 80% of patients undergoing surgery experience postoperative pain. Of these, 88% report that their pain is moderate, severe, or extreme.

The immediate- and extended-release components of Xartemis XR were formulated to provide the onset of pain relief in less than 1 hour and to allow twice-daily dosing. The medication is not interchangeable with other oxycodone/acetaminophen products because of differing pharmacokinetic profiles that affect the frequency of administration.

Xartemis XR is indicated for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. Because of the risks of addiction, abuse, misuse, overdose, and death with opioids, even at recommended doses, the product should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.

Xartemis XR contains oxycodone, a schedule II controlled substance. As an opioid, the medication exposes users to the risks of addiction, abuse, and misuse. Abuse or misuse of Xartemis XR by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxycodone and can result in overdose and death. The product’s approved label does not include abuse-deterrent language.

Source: Mallinckrodt; March 12, 2014.

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