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news.Winston Pharmaceuticals' wholly-owned subsidiary, Winston Laboratories, has submitted a new drug application (NDA) with the FDA for approval to market its Civanex, a civamide (zucapsaicin) 0.075% cream, for the treatment of signs and symptoms of osteoarthritis of the knee.
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Winston Pharma’s application is expected to be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2011.
Winston Pharma has submitted the NDA based on the results obtained from the randomised, double-blind, well-controlled clinical studies of Civanex.
Civanex clinical trial demonstrated that the patients treated with the drug experienced a 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.
Joel Bernstein, president and CEO of Winston, said: “In addition to this regulatory milestone, we have ongoing reviews of our marketing authorisation 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.”