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news.Xanodyne Pharmaceuticals has received an approvable letter from the FDA for Zipsor, its lead candidate for the treatment of patients with mild to moderate acute pain.
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Xanodyne’s Zipsor is a proprietary immediate release liquid-filled soft gelatin capsule containing 25mg of diclofenac potassium for oral administration. Zipsor is a unique formulation designed for rapid and consistent release while minimizing systemic exposure.
Xanodyne has previously submitted a new drug application (NDA) for Zipsor to the FDA. The NDA included data from four Phase III clinical trials of Zipsor in patients with acute pain following bunionectomy or dental surgery in which Zipsor achieved the primary efficacy endpoint of the trial, and was well-tolerated.
Gregory Flexter, president and CEO of Xanodyne, said: “Xanodyne is pleased with this action and will work closely with the FDA to provide a complete response. Importantly, no additional clinical trials have been requested.”