Nuvo resubmits Pennsaid NDA to FDA

Canadian drugmaker Nuvo Research says that it has resubmitted its New Drug Application relating to Pennsaid (diclofenac topical solution), a non-steroidal anti-inflammatory, to the US Food and Drug Administration. The product, which is intended to treat osteoarthritis of the knee, initially received a non-approvable letter from the agency due to concerns it had about the drug's safety and efficacy.

To address the FDA's concerns, the firm conducted a 12-week Phase III five-arm, double-blind assessment of the drug in 775 patients. The results of the study showed that the product had comparable efficacy to oral formulations in terms of pain, physical function and overall health assessment. An additional long-term study demonstrated that extended use of the drug did not cause any unexpected adverse events.