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Mallinckrodt’s pain drug XARTEMIS XR gets US FDA approval

Irish pharmaceutical firm Mallinckrodt has received approval from the US Food and Drug Administration (FDA) for its XARTEMIS XR extended-release tablets (CII), previously known as MNK-795, for the opioid treatment for acute pain.

XARTEMIS XR’s release profile combines Mallinckrodt’s newly patented technology, including design, formulation, pharmacokinetic and release characteristics, and Depomed’s advanced Acuform drug delivery technology.

The drug is the first and only extended-release oral combination of two pain medications oxycodone hydrochloride and acetaminophen.

XARTEMIS XR is indicated for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options are ineffective, not tolerated or would otherwise be inadequate.

The approval is based, in part, on the major Phase III efficacy trial conducted in an acute post-surgical pain model.

In the trial, XARTEMIS XR met the primary endpoint and showed significant improvement in pain scores compared to placebo from baseline over 48 hours.

The FDA approval triggers a $10m payment to Depomed under a license agreement signed by the two firms.

Depomed president and CEO Jim Schoeneck said the company expects to receive significant recurring royalty revenue from Mallinckrodt’s commercialization of XARTEMIS XR.

"Mallinckrodt has also licensed the Acuform delivery technology under equivalent royalty and milestone terms for its MNK-155 product candidate, which has been studied for moderate to severe acute pain," Schoeneck said.

"Mallinckrodt has indicated that it expects to file an NDA for MNK-155 in the second half of their 2014 fiscal year.

"FDA acceptance of the MNK-155 NDA would trigger a $5 million milestone payment to Depomed and approval by the FDA would trigger an additional $10 million milestone payment to Depomed."