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WASHINGTON -- Women who took 2.5 mg of frovatriptan either once or twice daily for 6 days at the time of menstruation had significantly fewer--and less severe--menstrual migraines, compared with women who took a placebo, reported Dr. Marie Pinizzotto and her colleagues at Endo Pharmaceuticals.
The women on either regimen of frovatriptan also reported significantly fewer headaches in general and less functional impairment compared with the placebo group. Data from the randomized, double-blind, three-way crossover study were presented in a poster at the annual meeting of the American College of Obstetricians and Gynecologists. The study was sponsored by Vernalis Development Ltd., and Endo Pharmaceuticals Inc.
Frovatriptan has been approved by the Food and Drug Administration for the acute treatment of migraines, both with and without aura, in adults, but it has not been approved for the prophylactic prevention of migraines. The manufacturers are seeking an additional indication for the prophylactic treatment of menstrual migraines.
The patients were randomized to receive each of the two treatment regimens or a placebo over the course of three different 6-day periods from 2 days before to 4 days after the onset of menstruation.
The incidence of pure menstrual migraines, defined as migraines that occurred during the time period from 2 days before to 3 days after the onset of menstruation, was ...