VERNON HILLS, Ill.--(BUSINESS WIRE)--Winston Pharmaceuticals, Inc. (OTC BB: WPHM) today announced that it has received 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. Winston 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® (Duloxetine) and Lyrica® (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.
