FDA to Review Zorvolex for Osteoarthritis Pain

Iroko Pharmaceuticals announced that the FDA has accepted for review the supplemental New Drug Application (sNDA) for Zorvolex (diclofenac), a lower dose nonsteroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis pain in adults.

The sNDA submission for Zorvolex was based on data from a 12-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial that enrolled 305 patients, aged 41-90 years, with osteoarthritis of the hip or knee. Participants were randomized to Zorvolex 35mg three times daily or 35mg twice daily, or placebo. The sNDA also included data from a 12-month open-label study that enrolled more than 600 patients.

Zorvolex was developed to address the FDA’s public health advisory recommending that NSAIDs be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Zorvolex is already approved for the treatment of mild to moderate acute pain in adults.

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