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Frovatriptan Prevents Difficult-to-Treat Menstrual Migraine: Presented at WCP

By Sara Freeman

GLASGOW, United Kingdom -- August 25, 2008 -- The ability of frovatriptan to prevent difficult-to-treat migraines is more than doubled if women anticipate the onset of symptoms.

These data, from a phase 3b study conducted in 55 centres in the United States and Europe were presented on August 21 at the 12th World Congress on Pain (WCP).

"Frovatriptan significantly decreased the incidence of menstrual migraine," according to the researchers, led by Jan Lewis Brandes, MD, Nashville Neuroscience Group, Tennessee. Treatment effects were approximately 2-fold greater in women who dosed correctly.

Correct dosing was defined as taking the drug 1 day before or after the start of the menses and the predicted onset of a migraine and continued for 6 days, and results were compared against those seen in women taking placebo or taking an incorrect dose of the drug.

Women with difficult-to-treat menstrual migraine and a history of nonresponse or of inadequate response to prior migraine therapies were randomised to placebo or to once- or twice-daily treatment with oral tablets of frovatriptan 2.5 mg.

Women in the once-daily frovatriptan group received an initial loading dose of 2 tablets in the morning of day 1, then 1 tablet per day on days 2 to 6. Women in the twice-daily frovatriptan group received a loading dose of 4 tablets on the first day (2 in the morning and 2 in the evening) on the first day, and then took 2 tablets on days 2 through 6.

One-third (34%) of 416 randomised women took their medication correctly for 3 consecutive premenstrual periods -- 58 in the placebo group; 45 taking frovatriptan once daily; 39 taking frovatriptan twice daily.

Results showed that the odds of being free of menstrual migraine for 1 or more premenstrual periods were significantly higher with frovatriptan than with placebo. In those who dosed the drug correctly, twice-daily frovatriptan was associated with an odds ratio of 3.75 (P = .002); the odds ratio with once-daily frovatriptan was 2.28 (P = .057).

Benefits over placebo were also seen in women who did not dose frovatriptan correctly, with odds ratios of 2.74 (P < .001) for twice-daily dosing and 1.72 (P = .02) for once-daily dosing.

Over time, the ability of frovatriptan to prevent menstrual migraine increased, with the incidence of menstrual migraine decreasing from 75% to 54% by the third premenstrual period. The incidence of menstrual migraine in placebo-treated patients remained high, at 86% in the first and 78% in the third premenstrual period.

Adverse events occurred in a similar percentage of placebo- and frovatriptan-treated patients, and most were rated mild or moderate in severity.

"These results suggest that short-term preventative treatment of menstrual migraine can be optimised," the researchers concluded, adding that "improved tools" need to be developed to help women identify the onset of menses-related migraine symptoms.

Funding for this study was provided by Vernalis Research & Development Ltd. and Endo Pharmaceuticals Inc.

[Presentation title: Efficacy of Scheduled Short-Term Preventative Frovatriptan in Women Who Accurately Predicted Onset of Menses. Abstract PH276]

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