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Civanex

Generic name: zucapsaicin
Treatment for: Osteoarthritis

NDA Submitted for Civanex

Winston Laboratories, Inc. Submits NDA for Civanex (Civamide Cream) for Treatment of Osteoarthritis

VERNON HILLS, Ill.--(BUSINESS WIRE)--Jul 7, 2010 - Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. ("Winston") a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, Civanex, for the treatment of signs and symptoms of osteoarthritis of the knee. Winston anticipates that the application will be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2011.

The NDA submission is supported by randomized, double-blind, well-controlled clinical studies of Civanex in more than 1,200 patients. Clinical trials show that Civanex-treated patients experienced a statistically significant reduction in the Western Ontario and McMaster Universities Arthritis Index ("WOMAC") Pain scale, the WOMAC Physical Function Subscale and a Patient Global Evaluation over a 12-week treatment period, relative to those in a lower dose control group. Since there is no systemic absorption of civamide, Civanex can be administered either as a monotherapy or in combination with other systemic pain relief medications. The most common adverse reactions associated with Civanex were transient burning or stinging at the application site.

"We are pleased to have submitted our NDA for Civanex in the United States," said Joel E. Bernstein, M.D., President and CEO of Winston. "In addition to this regulatory milestone, we have ongoing reviews of our marketing authorization application (MAA) in the European Union and our new drug submission (NDS) in Canada. We anticipate a decision on the NDS in the third quarter of 2010, and eagerly anticipate the commercial launch of Civanex in both North America and the European Union."

About Osteoarthritis

Osteoarthritis is the most common form of arthritis, affecting more than 21 million Americans, mainly adults over age 45. Women are more susceptible to this condition. Osteoarthritis affects the fingers, spinal column and weight-bearing joints such as the hips, knees and feet. The main symptom of osteoarthritis is pain, the degree of which ranges from mildly inconvenient to debilitating. By 2030, an estimated 67 million Americans aged 18 years or older will have doctor-diagnosed arthritis. For some patients with osteoarthritis, relief of mild-to-moderate joint pain is afforded by acetaminophen (e.g. Tylenol) or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (e.g. Motrin, Advil, etc.), but even these OTC medications have systemic side effects and drug interactions. A topical medication without systemic absorption, which can be utilized as either monotherapy or adjunctive therapy absent risk of systemic side effects or drug interactions, would be quite advantageous. Alternate approaches include intra-articular therapies such as hyaluronic acid and glucocorticoids.

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 product candidates include osteo- and rheumatoid arthritis, neuropathic pain, episodic cluster headache, chronic daily headache, and pain and inflammation in inflammatory bowel disease.

About Civamide

Civamide (zucapsaicin; chemical name: cis-8-methyl-N-vanillyl-6-nonenamide) is a patented, synthetically produced TRPV-1 receptor modulator, which selectively depresses the activity of the type-C pain fibers. Civamide causes an initial release of the neuropeptides, substance P (SP) and calcitonin-gene related peptide (CGRP). Pain transmission and inflammation is then diminished by the subsequent depletion of SP and CGRP from the neuron, coupled with suppression of the synthesis and transport of neuropeptides along the neuron.

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: July 2010

Civanex (zucapsaicin) FDA Approval History

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