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 in the study 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 significantly lower in both frovatriptan groups, compared with placebo.
These distinctive headaches occurred in 38% of the twice-daily frovatriptan group, compared with 51% of the once-daily group and 67% of the placebo group.
The intent-to-treat analysis included 179 women aged 18 years and older with at least a 1-year history of menstrually-related migraines. The mean age was 37 years, and 82% were white. On average, the study participants had a history of migraines greater than 10 years, and the average number of migraine attacks was one per month during the year prior to the study.
Moderate to severe headaches were reported by 25%, 32%, and 46% of women in the twice-daily frovatriptan, once-daily frovatriptan, and placebo groups, respectively. The incidence of functional impairment was 14%, 24%, and 35%, respectively.
Adverse events seen in the study included headache, nausea, dizziness, and nasopharyngitis. The incidence of these events was similar between the two groups, with the exception of upper respiratory tract infections, which were significantly more common in the patients treated with twice-daily frovatriptan.