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FDA Agrees to Review Zorvolex (Diclofenac) for OA Pain in Adults

First lower-dose NSAID using fine-particle technology (January 15)

The FDA has accepted for review a supplemental New Drug Application (sNDA) for Zorvolex (diclofenac, Iroko Pharmaceuticals), a lower-dose nonsteroidal anti-inflammatory drug (NSAID), for the proposed indication of the treatment of osteoarthritis (OA) pain in adults. The drug was approved by the FDA in October 2013 for the treatment of mild-to-moderate acute pain in adults.

The sNDA for Zorvolex in the treatment of OA pain included data from a 12-week, randomized, double-blind, parallel-group, placebo-controlled trial that enrolled 305 patients, aged 41 to 90 years, with OA of the hip or knee. The participants were randomly assigned to receive Zorvolex 35 mg (twice daily or three times daily) or placebo. Data from this study were presented at the World Congress on Osteoarthritis in April 2013. The sNDA also included data from a 12-month open-label study that enrolled more than 600 patients.

Zorvolex is the first lower-dose FDA-approved NSAID developed using a proprietary fine-particle technology. The product contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. Zorvolex was developed to align with recommendations from the FDA and other professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals.

Source: Iroko Pharmaceuticals; January 15, 2014.

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