Drug for Osteoarthritis of the Knee Up for Review

A new drug for the treatment of signs and symptoms of osteoarthritis of the knee is up for review by the FDA. The drug, CIVANEX®, which is a civamide (zucapsaicin) 0.075% cream, is developed by Winston Laboratories, Inc. The pharmaceutical company has submitted an application with the FDA to begin marketing the new drug.

The drug has been tested through randomized, double-blind, well-controlled clinical studies in more than 1,200 patients. It can be administered “either as a monotherapy or in combination with other systemic pain relief medications.”

"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 a press release. "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."