Nuvo's partner Mallinckrodt to resubmit osteoarthritis treatment to US FDA

Canada’s Nuvo Research (TSX: NRI) says that its licensing partner Mallinckrodt (NYSE: MNK) has successfully completed a pharmacokinetic (PK) study comparing Pennsaid 2% w/w (diclofenac sodium topical solution) to original Pennsaid, used for treating the signs and symptoms of osteoarthritis of the knee.

On March 4, which the FDA had set as the Prescription Drug User Fee Act (PDUFA) date for action, Mallinckrodt – a company recently spun-out from Covidien ( The Pharma Letter May 27) - received a Complete Response Letter from the US Food and Drug Administration following the review of Mallinckrodt’s New Drug Application for Pennsaid 2%. In the letter, the FDA required that Mallinckrodt successfully complete the PK study.

Mallinckrodt has indicated to Nuvo, a specialty pharmaceutical firm creating products for the topical treatment of pain, that it expects to send the Pennsaid 2% resubmission to the FDA within the next 60 days. Mallinckrodt anticipates the FDA will provide a formal response to the filing within six months of the submission.