FDA approves Zorvolex (Iroko Pharma) for Mild to Moderate Pain
The FDA has approved Zorvolex (diclofenac) capsules, from Iroko Pharma, for the treatment of Mild to Moderate Acute Pain in adults. FDA approval of Zorvolex 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.
Zorvolex 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. The drug was approved at dosage strengths that are 20% lower than currently available diclofenac products.
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