Winston Pharmaceuticals, Inc. (“Winston”), a specialty pharmaceutical company focused on developing and commercializing novel pain management therapies, announced the results of its Phase II study on its patented Dolorac® Nasal Solution (doxepin 0.4%) for prophylaxis of chronic migraine (“CM”) at the Lazard Capital Markets 7th Annual Healthcare Conference in New York.
In the 210 patient Phase II double-blind, vehicle-controlled, multi-center study on patients with ≥180 headache days per year, twice-daily administration of Dolorac was significantly more effective than control in improving the primary efficacy variables of Headache Duration and Patient Global Satisfaction (P=0.0013 and P=0.0002, respectively). Winston expects to initiate two Phase III pivotal studies, each enrolling 300-350 patients with CM in Q2 2011.
Joel E. Bernstein, M.D., Winston’s President and Chief Executive Officer, commented, “There are as many as 12 million patients with CM in the U.S. and a similar number in the European Union. Taking into account the chronicity of the condition and the large number of CM sufferers, this is a very large market.”
Dr. Bernstein added, “The only product approved for prophylaxis of CM is Botox®, and this treatment requires 31 injections into the head and neck every 12 weeks. Furthermore, Botox treatment is accompanied by a number of not infrequent serious side effects, and will cost the patient in excess of $20,000 per year. The over 500 patients who have utilized Dolorac nasal solution have experienced no systemic side effects, and Dolorac requires just one spray in each nostril twice daily. Consequently, Dolorac has significant safety, convenience and pharmaco-economic advantages over Botox injections.”
Source: Winston Pharmaceuticals