Winston Laboratories, Inc. Submits NDA For CIVANEX(R) (Civamide Cream) For Treatment Of Osteoarthritis

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 submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, CIVANEX®, for the treatment of signs and symptoms of osteoarthritis of the knee. Winston anticipates that the application will be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2011.


The NDA submission is supported by randomized, double-blind, well-controlled clinical studies of CIVANEX® in more than 1,200 patients. Clinical trials show that 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 either as a monotherapy or 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 pleased to have submitted our NDA for CIVANEX® in the United States," said Joel E. Bernstein, M.D., President and CEO of Winston. "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."


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