Winston Pharma gets orphan status for civamide

Illinois, USA-based Winston Pharmaceuticals has received Orphan Drug designation from the Food and Drug Administration 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 (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.

Joel Bernstein, chief executive of Winston, said that "the civamide  patch represents a quantum advance over current topical therapies for  neuropathic pain."