FDA Approves Iroko’s Zorvolex

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 placebo.
 
Iroko developed Zorvolex capsules under a collaboration and license agreement with iCeutica utilizing iCeutica’s SoluMatrix Fine Particle Technology, a platform that uses a dry milling process to make finely dispersed drug particles that are 10 – 200 times smaller than conventional drug particles. The SoluMatrix process has the potential to create drugs that work faster and more effectively at lower doses.