FDA approves Mallinckrodt's oxycodone/acetaminophen

FDA approved an NDA from Mallinckrodt plc (NYSE:MNK) for Xartemis XR oxycodone/acetaminophen ( MNK-795) to manage acute pain severe enough to require the use of an opioid analgesic and when alternative treatment options are ineffective, not tolerated or would otherwise be inadequate. The label does not include abuse-deterrent language, but Mallinckrodt is collecting data to characterize the abuse-deterrence features of Xartemis.

The approval triggers a $10 million milestone payment from Mallinckrodt to Depomed Inc. (NASDAQ:DEPO). The controlled-release oral formulation of oxycodone and acetaminophen is formulated using Depomed's AcuForm gastric retentive formulation technology. Depomed is also eligible for single-digit royalties. ...