Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., has received Notice of Compliance (NOC) from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission (NDS) for CIVANEX (TM) (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.
“Osteoarthritis can be an excruciating painful condition that can affect many aspects of a patient’s quality of life,” said Joel E. Bernstein, M.D., President and CEO of Winston. “Civanex may provide a unique treatment option for these types of patients in combination with existing therapies.”
In clinical trials, CIVANEX(TM)-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(TM) can be administered in combination with other systemic pain relief medications. The most common adverse reactions associated with CIVANEX(TM) were transient burning or stinging at the application site.
“We are delighted to have received Health Canada’s approval to provide this pain management therapy to the many patients and physicians looking for new ways to manage osteoarthritis” said Dr. Bernstein. “The approval of CIVANEX(TM) is an important early milestone towards Winston’s goal of eventually becoming a worldwide leader in pain management. In addition to the Canadian approval of Civanex, our marketing authorization application (MAA) in the European Union and new drug admission (NDA) in United States are currently under review. We eagerly anticipate the commercial launch of CIVANEX(TM) in Canada, the United States and the European Union. We are especially excited about completing development of our other late-stage products, including those for neuropathic pain (postherpetic neuralgia and diabetic radiculopathy), cluster headache, and Crohn’s disease.”