Winston Pharmaceuticals, Inc. Announces Positive Results of Phase II Clinical Trial of Dolorac Nasal Solution

VERNON HILLS, Ill.--(BUSINESS WIRE)--Nov 22, 2010 - Winston Pharmaceuticals, Inc. (“Winston”), a specialty pharmaceutical company focused on developing and commercializing novel pain management therapies, announced the results of its Phase II study on its patented Dolorac® Nasal Solution (doxepin 0.4%) for prophylaxis of chronic migraine (“CM”) at the Lazard Capital Markets 7th Annual Healthcare Conference in New York.

In the 210 patient Phase II double-blind, vehicle-controlled, multi-center study on patients with ‰¥180 headache days per year, twice-daily administration of Dolorac was significantly more effective than control in improving the primary efficacy variables of Headache Duration and Patient Global Satisfaction (P=0.0013 and P=0.0002, respectively). Winston expects to initiate two Phase III pivotal studies, each enrolling 300-350 patients with CM in Q2 2011.

Joel E. Bernstein, M.D., Winston's President and Chief Executive Officer, commented, “There are as many as 12 million patients with CM in the U.S. and a similar number in the European Union. Taking into account the chronicity of the condition and the large number of CM sufferers, this is a very large market.”

Dr. Bernstein added, “The only product approved for prophylaxis of CM is Botox®, and this treatment requires 31 injections into the head and neck every 12 weeks. Furthermore, Botox treatment is accompanied by a number of not infrequent serious side effects, and will cost the patient in excess of $20,000 per year. The over 500 patients who have utilized Dolorac nasal solution have experienced no systemic side effects, and Dolorac requires just one spray in each nostril twice daily. Consequently, Dolorac has significant safety, convenience and pharmaco-economic advantages over Botox injections.”

About Winston Pharmaceuticals

Winston is a pharmaceutical company focused on pain control which 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 late stage candidates include episodic cluster headache, chronic migraine headache, osteo-and rheumatoid arthritis, neuropathic pain, and pain and inflammation in inflammatory bowel disease.

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, (847) 362-8200

 

Posted: November 2010

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