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news.The Therapeutics Drug Directorate of Health Canada has issued notice of compliance (NOC) to Winston Laboratories, a wholly-owned subsidiary of Winston Pharmaceuticals, for its new drug submission (NDS) for Civanex (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.
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In a trial, Civanex showed 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.
Winston said that Civanex can be administered in combination with other systemic pain relief medications as there is no systemic absorption of civamide.
Joel Bernstein, president and CEO of Winston, said: “We are delighted to have received Health Canada’s approval to provide this pain management therapy to the patients and physicians looking for ways to manage osteoarthritis.
“In addition to the Canadian approval of Civanex, our marketing authorisation application (MAA) in the EU and new drug admission (NDA) in US are currently under review.”