Winston Pharmaceuticals announced the results of its Phase 2 study of Dolorac (doxepin 0.4% nasal solution) for prophylaxis of chronic migraine (CM). In this 210 patient 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 3 pivotal studies, each enrolling 300-350 patients with CM in Q2 2011.  

Dolorac nasal solution contains doxepin, a tricyclic antidepressant with anxiolytic properties. 

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