Trials & Filings

FDA Approves Iroko’s Zorvolex

Pain treatment uses iCeutica’s SoluMatrix Fine Particle Technology

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Iroko Pharmaceuticals received approval from the FDA for Zorvolex (diclofenac) 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 currently available diclofenac products.   The approval was supported by data from a Phase III multi-center, randomized study in which patients treated with Zorvolex reported significant pain relief compared with patients receiving placeb...

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