FDA approves NSAID to address dose-related safety concerns

The FDA has approved diclofenac (Zorvolex) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild-to-moderate acute pain in adults. Zorvolex was approved at dosage strengths that are 20% lower than what is currently available. A phase 3 multicenter, randomized study showed that patients reported significant pain relief when treated with diclofenac as compared to placebo.

Zorvolex was developed to align with public health recommendations by FDA and other medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration of time. Risk of serious adverse events and renal events are associated with higher doses. Zorvolex is the only NSAID developed using proprietary SoluMatrix Fine Particle Technology. It contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in size leads to faster dissolution.

Iroko Pharmaceuticals  (267) 546.3003  www.iroko.com

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