Depomed, a specialty pharmaceutical company, announced that the US Food and Drug Administration (US FDA) has accepted for filing a New Drug Application (NDA) 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.

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.

"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," said Jim Schoeneck, president and chief executive officer, of Depomed.  "Depomed's proprietary Acuform drug-delivery technology is also being used (under similar royalty terms) by Mallinckrodt in XARTEMIS XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), an extended-release oral formulation of oxycodone and acetaminophen approved for management of acute pain severe enough to require use of an opioid analgesic. We believe that the combination of royalties on net sales of XARTEMIS XR and additional milestones and royalties on MNK-155, if it is approved, can make a significant contribution to Depomed's future revenues."