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.”