US regulators will carry out a speedy review of Depomed and Mallinckrodt’s experimental pain drug MNK-795.
The move means that the companies can expect a decision by the US Food and Drug Administration within six months instead of the usual 10.
MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen, in development for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
The submission to the US Food and Drug Administration is based on data from a comprehensive clinical trial program for the drug, which includes 14 clinical studies with 1,281 patients.
“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,” commented Mark Trudeau, Mallinckrodt’s chief executive.
As the product was formulated with Depomed’s Acuform drug delivery technology, which reduces the risk of abuse as it delivers active substances to the upper gastrointestinal tract in a controlled manner, the group now stands to receive a $5-million milestone payment.
Under its deal with Depomed, it is also entitled to an additional milestone payment upon approval of the NDA, and high single digit royalties on net sales.
