FDA accepts NDA for investigational extended-release oral formulation of hydrocodone/APAP

NEWARK, Calif. — Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt 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. 

"We are pleased that the FDA has accepted the NDA for MNK-155 for filing, and we look forward to potential approval of this extended-release product," stated Jim Schoeneck, president and CEO Depomed. "Depomed's proprietary Acuform drug-delivery technology is also being used … by Mallinckrodt in Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablets, an extended-release oral formulation of oxycodone and acetaminophen approved for management of acute pain severe enough to require use of an opioid analgesic."

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.