US FDA grants priority review for Mallinckrodt's pain relief drug

The US Food and Drug Administration has accepted and granted a priority review for the New Drug Application for MNK-795 from US drug manufacturer Mallinckrodt (NYSE: MNK).

MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. FDA priority review is used for drugs that, if approved, offer significant improvements in the safety or effectiveness of the treatment when compared to standard applications.

Mark Trudeau, Mallinckrodt president and chief executive, said: “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. We are pleased the FDA granted priority review designation. Mallinckrodt has unique capabilities in complex formulations such as MNK-795 and this marks an important milestone for us as our first NDA acceptance as an independent specialty pharmaceutical company.”