Winston Laboratories, Inc., Vernon HIlls, Ill, announced that it has received Notice of Compliance (NOC) from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission (NDS) for CIVANEX ™ (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.
Joel E. Bernstein, M.D., President and CEO of Winston, said in the news release, “Civanex may provide a unique treatment option for these types of patients in combination with existing therapies.”
In clinical trials, 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 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.
In addition to the Canadian approval of Civanex, the company has submitted a marketing authorization application (MAA) in the European Union and a new drug admission (NDA) in United States, which are currently under review.
(Source: Press Release)
