Winston Pharmaceuticals, Inc. Receives Orphan Drug Designation For Novel Patch To Treat Post-Herpetic Neuralgia

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Feb 2009 - 6:00 PDT

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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.

"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," stated 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."

About Post-Herpetic Neuralgia

Post-herpetic neuralgia (PHN), is the pain persisting for at least 3 months after a herpes zoster eruption (commonly referred to as "shingles") heals and is the most feared complication of the disorder. 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.

About Orphan Drug Designation

FDA orphan drug designation is designed to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases which affect fewer than 200,000 people in the United States. Administered by the Office of Orphan Drug Products, potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, tax credit, and importantly, up to seven years of marketing exclusivity upon approval of the NDA are provided.

About Winston Pharmaceuticals

Winston Pharmaceuticals is a development stage 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 arthritis, neuropathic pain, cancer pain, post-operative pain, cluster headache and chronic daily headache.

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

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