FDA Approves First ER Oxycodone Acetaminophen Combo

FDAThe 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.

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