FDA Accepts Mallinckrodt's MNK-155 NDA For Review

(RTTNews) - Depomed, Inc. (DEPO) said Wednesday that the U. S. Food and Drug Administration has accepted for filing a New Drug Application from Mallinckrodt plc (MNK) for MNK-155. MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen that has been studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. MNK-155 is formulated with Depomed's Acuform drug delivery technology.

The NDA acceptance triggers a $5 million milestone payment to Depomed under a license agreement between Depomed and Mallinckrodt. Depomed is also entitled to an additional milestone payment of $10 million upon approval of the NDA and high single digit royalties on net sales of MNK-155, if approved.