Winston Pharmaceuticals Announces Positive Top-line Results of Phase I Clinical Trial of Civamide Patch
VERNON HILLS, Ill.--(BUSINESS WIRE)--Feb 9, 2009 - Winston Pharmaceuticals, Inc. today announced positive top-line results from Study WL1001-04-01, a Phase I clinical trial evaluating the tolerability and pharmacokinetic profile of two concentrations of the company's patch formulation of Civamide, a novel TRPV-1 receptor modulator. The study successfully demonstrated the tolerability of the two concentrations tested for continuous application to the skin for a period of one week. Additionally, there was no systemic absorption of civamide detected in any patients, supporting its local use for the topical treatment of post-herpetic neuralgia.
Study WL1001 -04 -01 was a randomized, double-blind, placebo-controlled, single-center study of 38 patients designed to evaluate the safety and tolerability of two strengths of Civamide Patch, 0.0075% and 0.015%, versus placebo. In this study, a patch was applied once daily to the same area of the abdomen, and worn for 24 hours before replacing with a new patch during the 7 day study duration. Both strengths of the Civamide Patch were tolerable, with all subjects completing the study and with all but one subject being able to wear the patch for the entire 7 day period. Subjects applying active Civamide Patches experienced transient burning sensations which progressively lessened or resolved with each application during the study. Based upon the favorable results of this study, Winston is now initiating a Phase II study of the 0.015% Civamide patch for treatment of post-herpetic neuralgia. The lack of systemic absorption should permit the use of the Civamide Patch adjunctively with systemic medications such as Cymbalta® (Pregabalin) and Lyrica® (Duloxetine) without the risk of drug-drug interactions.
"We are pleased with the successful completion of formulation development and the Phase I study on the Civamide Patch,” stated Joel E. Bernstein, MD, President and Chief Executive Officer of Winston Pharmaceuticals, Inc. "The Civamide Patch represents a quantum advance over current topical and patch therapies for neuropathic pain.”
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 osteoarthritis, neuropathic pain, cancer pain, post-operative pain, episodic 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.
Contact: Winston Pharmaceuticals, Inc.
David Starr, Chief Financial Officer
Posted: February 2009