Winston Pharmaceuticals, Inc. announced that it has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for its lead compound, Civamide, a novel TRPV-1 receptor modulator being developed as a dermal patch for the treatment of post-herpetic neuralgia. The company recently released results of a Phase I study demonstrating the patch’s ease of use with repeated 24-hour applications.
The lack of systemic absorption of Civamide from the patch should permit its use as either a monotherapy or as adjunctive therapy in combination with systemic medications used to treat post-herpetic neuralgia such as Cymbalta(R) (Duloxetine) and Lyrica(R) (Pregabalin), without a risk of drug-drug interactions. Winston is currently conducting a Phase II study of the Civamide Patch in patients with chronic post-herpetic neuralgia.
“FDA orphan drug designation provides multiple incentives for the development of Winston’s Civamide Patch. Such designation will permit the accelerated development and availability of the Civamide Patch to patients suffering from this extremely painful condition,” commented Joel E. Bernstein, MD, President and Chief Executive Officer of Winston Pharmaceuticals, Inc. “The Civamide Patch represents a quantum advance over current topical therapies for neuropathic pain.”