Iroko announced that the Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules for the management of osteoarthritis pain.

Zorvolex is a low-dose nonsteroidal anti-inflammatory drug (NSAID) that utilizes SoluMatrix Fine Particle Technology. It contains diclofenac submicron particles that are about 20 times smaller than their original size.

The approval for the management of osteoarthritis pain was based on data from a 12-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial that enrolled 305 patients with osteoarthritis of the hip or knee. Participants were randomized to Zorvolex 35mg three times daily or 35mg twice daily, or placebo.

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Zorvolex was approved in October 2013 for the treatment of mild to moderate pain in adults. Zorvolex is available in 18mg or 35mg strength capsules in 30- and 90-count bottles.

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