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news.Winston Pharmaceuticals has released results of its Phase II study on its patented Dolorac Nasal Solution (doxepin 0.4%) for prophylaxis of chronic migraine (CM).
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Winston’s trial showed that, in the 210 patient Phase II double-blind, vehicle-controlled, multi-center study on patients with more than 180 headache days per year, twice-daily administration of Dolorac was more effective than control in improving the primary efficacy variables of Headache Duration and Patient Global Satisfaction.
Winston expects to initiate two Phase III pivotal studies, each enrolling 300-350 patients with CM in Q2 2011.
Winston president and CEO Joel Bernstein said that the only product approved for prophylaxis of CM is Botox, and this treatment requires 31 injections into the head and neck every 12 weeks.
"The over 500 patients who have utilised Dolorac nasal solution have experienced no systemic side effects, and Dolorac requires just one spray in each nostril twice daily," Bernstein said.
"Consequently, Dolorac has significant safety, convenience and pharmaco-economic advantages over Botox injections."