WPHM Winston Pharmaceuticals Inc (CE)

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 Winston Pharmaceuticals

Winston Pharmaceuticals is a pharmaceutical company focused on pain control. Winston is developing products for large pain control markets, as well as for niche markets, where there are still significant unmet needs for pain management options with improved efficacy, safety, and tolerability profiles. Winston’s product candidates span a range of pain indications, including neuropathic pain, cancer pain, post-operative pain, episodic cluster headache, chronic daily headache and osteoarthritis.

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.

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product development efforts and other non-historical facts about expectations, beliefs or intentions regarding the business, technologies and products, financial condition, strategies or prospects. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that any products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the ailments being studied or for other ailments. In addition, forward-looking statements also may be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. We do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Winston Pharmaceuticals (CE) (USOTC:WPHM)
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Winston Pharmaceuticals (CE) (USOTC:WPHM)
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