Mallinckrodt's MNK-795 gets Priority Review for pain

FDA accepted and granted Priority Review to an NDA from Mallinckrodt plc (NYSE:MNK) for MNK-795 to manage moderate to severe acute pain where the use of an opioid analgesic is appropriate. The company submitted the NDA in late May but declined to disclose the PDUFA date.

The acceptance triggers a $5 million milestone payment to Depomed Inc. (NASDAQ:DEPO) from Mallinckrodt. MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen formulated using Depomed's AcuForm gastric retentive formulation technology. ...