Winston Laboratories, Inc. Announces Positive Top-line Results Of Phase II Clinical Trial Of Civamide Patch

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials
Article Date: 18 Nov 2009 - 0:00 PDT

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Winston Laboratories, Inc. ("Winston Labs"), a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. (OTC BB: WPHM) today announced positive top-line results from Study WL1001-04-03, a Phase II clinical trial evaluating the safety and efficacy of the company's patch formulation of Civamide, a novel TRPV-1 receptor modulator in the treatment of post-herpetic neuralgia (PHN). The study successfully demonstrated the efficacy of Civamide Patch 0.015% in reducing pain and improving sleep in as little as one week of applying the patch to the skin affected by PHN with 40% or greater improvement in both parameters at the end of the 4 week study.

Study WL1001-04-03 was an open-label multi-center study of 20 patients with chronic, intractable PHN, unresponsive or poorly responsive to standard oral therapies, and was designed to evaluate the safety and efficacy of Civamide Patch 0.015%. In this study, a single patch was applied once daily to the area of the trunk affected by PHN and worn for 12 to 24 hours before replacing with a new patch during the 28 day treatment duration. Patients experienced transient burning sensations which progressively lessened or resolved with each application during the study. Based upon the favorable results of this study, Winston plans on initiating two Phase III pivotal studies of the patch for the treatment of PHN. The lack of any systemic absorption previously demonstrated in Phase I should permit the use of the Civamide Patch adjunctively with systemic medications such as Cymbalta® (Duloxetine) and Lyrica® (Pregabalin) without the risk of drug-drug interactions. "We are pleased with the efficacy demonstrated by the Civamide Patch in the Phase II study," said Joel E. Bernstein, MD, Winston's President and Chief Executive Officer. "Compared to the currently available therapies for PHN, whether oral, topical, or patch, Civamide Patch 0.015% has both efficacy and safety advantages over each of them."

Winston Pharmaceuticals, Inc. previously announced that it had received Orphan Drug Designation from the FDA for the Civamide patch for the treatment of PHN.

About Post-Herpetic Neuralgia

Post-herpetic neuralgia (PHN), is the chronic pain persisting for at least 3 months after a herpes zoster eruption (commonly referred to as "shingles") heals. PHN may occur in almost any area, but is especially common on the trunk. It is the most feared complication of the disorder as the pain is often severe and can persist for as long as 10 or more years, leading to serious compromises in quality of life, including depression and suicide. No treatments, oral or topical, have proven universally beneficial or practical, given their side effect profiles and the limitations of their efficacy.

Source
Winston Pharmaceuticals

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