Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals 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."

(Source: Press Release)