Winston Laboratories, Inc. Receives Notice Of Compliance In Canada For CIVANEX™ (Civamide Cream) For Treatment Of Osteoarthritis

Main Category: Bones / Orthopedics
Also Included In: Arthritis / Rheumatology
Article Date: 22 Jul 2010 - 2:00 PDT

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Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. ("Winston") (OTC PINK: WPHM), a pharmaceutical company focused on developing and commercializing novel pain management therapies, 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.

"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™-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.

"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™ 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™ 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."

About Osteoarthritis

Osteoarthritis is the most common form of arthritis, affecting more than 21 million Americans, mainly adults over age 45. Women are more susceptible to this condition. Osteoarthritis affects the fingers, spinal column and weight-bearing joints such as the hips, knees and feet. The main symptom of osteoarthritis is pain, the degree of which ranges from mildly inconvenient to debilitating. By 2030, an estimated 67 million Americans aged 18 years or older will have doctor-diagnosed arthritis. For some patients with osteoarthritis, relief of mild-to-moderate joint pain is afforded by acetaminophen (e.g. Tylenol®) or a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen (e.g. Motrin®, Advil®, etc.), but even these OTC medications have systemic side effects and drug interactions. A topical medication without systemic absorption, which can be utilized as either monotherapy or adjunctive therapy absent risk of systemic side effects or drug interactions, would be quite advantageous. Alternate approaches include intra-articular therapies such as hyaluronic acid and glucocorticoids.

About Civamide

Civamide (zucapsaicin; chemical name: cis-8-methyl-N-vanillyl-6-nonenamide) is a patented, synthetically produced TRPV-1 receptor modulator, which selectively depresses the activity of the type-C pain fibers. Civamide causes an initial release of the neuropeptides, substance P (SP) and calcitonin-gene related peptide (CGRP). Pain transmission and inflammation is then diminished by the subsequent depletion of SP and CGRP from the neuron, coupled with suppression of the synthesis and transport of neuropeptides along the neuron.

Source:
Winston Pharmaceuticals

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