FDA Approves First ER Oxycodone Acetaminophen Combo

The US Food and Drug Administration (FDA) has approved an extended-release combination of oxycodone and acetaminophen (Xartemis XR, Mallinckrodt plc), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment, and for patients for whom alternative treatment options are ineffective, not tolerated, or would otherwise be inadequate.

The drug has both immediate- and extended-release components to allow pain relief within an hour, with twice-daily dosing, the company notes in a statement issued today.

Approval is based in part on results of a phase 3 trial in an acute post-surgical pain model of bunionectomy; results were presented last fall during PAINWeek 2013, and reported by Medscape Medical News at that time. The new formulation met the primary endpoint and showed statistically significant improvement in pain scores vs placebo from baseline over 48 hours.

The new formulation’s release profile combines Mallinckrodt’s patented technology, including design, formulation, pharmacokinetic and release characteristics, and Depomed’s advanced Acuform drug delivery technology, the statement adds.

In addition to the efficacy study, Mallinckrodt did extensive laboratory testing and human abuse liability study with the extended-release combination product, also reported in 15 scientific presentations during PAINWeek.

“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 said. “The company is conducting additional studies and will be providing additional data in the near future.”

Oxycodone is a Schedule II controlled substance, and exposes patients and other uses to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, the release notes. “Assess each patient’s risk prior to prescribing Xartemis XR, and monitor all patients regularly for the development of these behaviors or conditions.”