Xartemis XR Approved for Severe Acute Pain

Mallinckrodt announced that the FDA has approved Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets (formerly known as MNK-795) for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative options are ineffective, not tolerated or would otherwise be inadequate. This Schedule II substance is the first extended-release oral combination of oxycodone and acetaminophen.

Xartemis XR is designed to provide pain relief in less than one hour. It utilizes Mallinckrodt’s patent technology in its design, formulation, pharmacokinetic and release characteristics, as well as Depomed’s advanced Acuform drug delivery technology.

The FDA approval is based on the Phase 3 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 vs. placebo from baseline over a 48-hour period. Additional lab testing and a human abuse liability study were conducted as well.

Oxycodone HCl is an opioid agonist and is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses providing analgesia. Acetaminophen is a non-opioid, non-salicylate analgesic, and antipyretic that inhibits the endogenous pyrogen action on the hypothalamic heat-regulating centers

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