Analgesia specialists Iroko Pharmaceuticals have announced that the US Food and Drug Administration has approved Zorvolex (diclofenac) capsules for the treatment of mild to moderate acute pain in adults.
Zorvolex, a nonsteroidal anti-inflammatory drug (NSAID), was approved at dosage strengths that are 20% percent lower than currently available diclofenac products. 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.
John Vavricka, president and chief executive of Iroko Pharmaceuticals, said: “The approval of Zorvolex is important news for patients and for physicians who need new options for effective pain relief, and is a significant milestone for Iroko. This marks a major achievement towards our goal of applying new technology to existing NSAIDs in order to address unmet medical needs in analgesia.”
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