Mallinckrodt has won priority review from the US Food and Drug Administration (FDA) for its pain drug MNK-795.
The designation is granted to drugs that offer significant improvements in the safety or effectiveness of the treatment, and can cut down the regulatory process from 10 to six months.
Mallinckrodt is a controlled-release oral formulation of oxycodone and acetaminophen, and is intended for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
“Despite the number of available pain medications, patients continue to experience unresolved pain and lack treatment options that offer fast-acting and long-lasting relief,” said Mark Trudeau, president and CEO of Missouri-based Mallinckrodt.
“Mallinckrodt has unique capabilities in complex formulations such as MNK-795 and this marks an important milestone for us as our first New Drug Application (NDA) acceptance as an independent specialty pharmaceutical company.”
The drug was originally developed using technology from Depomed, which signed a license agreement with Mallinckrodt.
As a result of the FDA accepting Mallinckrodt’s NDA, Depomed is entitlted to a $5m milestone payment.
“We are pleased that the FDA has accepted the NDA for MNK-795 for filing, and we look forward to potential approval of this product,” said Jim Schoeneck, president and CEO of Depomed, who explained that Mallinckrodt is also using Depomed’s technology to develop another drug.
“Depomed’s proprietary Acuform drug-delivery technology is also being used (under similar milestone and royalty terms) by Mallinckrodt in development of another pipeline product that is being studied in patients with acute, moderate to severe pain,” he said.
“Should either or both of these products be approved, we believe that the combination of milestones and royalties on net sales can make a significant contribution to Depomed’s future revenues.”