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Frova Phase III Study Data Demonstrates That Short-Term Prevention,Treatment Reduces Frequency and Severity of Menstrual Migraine

ents with menstrual migraine and predictable menses, I am intrigued by the potential for a short-term prevention treatment to prevent or minimize MM symptoms without continuously exposing patients to a drug," said Stephen Silberstein, M.D., professor of neurology at the Jefferson Medical College of Thomas Jefferson University, director of the Jefferson Headache Center and lead investigator of the initial efficacy study of FROVA for the short-term prevention of menstrual migraine.

Study Results

In the trial, the MM status of study participants was confirmed during a placebo-controlled, single-blind, run-in phase. Women were randomized in the double-blind study to receive FROVA 2.5 mg once a day, FROVA 2.5 mg twice a day, or placebo (ratio 3:2:3).

FROVA once or twice daily significantly improved the number of headache-free perimenstrual periods (PMPs) compared to women who received placebo. FROVA also significantly reduced the incidence of severe migraines and therefore tended to improve the ratio of severe to mild headache compared to women who received placebo. Efficacy data were collected from 410 women in North America and Europe, 85 percent of whom participated in the study over three PMPs. Efficacy data were collected from 410 women in North America and Europe, 85 percent of whom participated in the study over three PMPs.

The study's primary endpoint was the number of completely headache-free PMPs. FROVA therapy significantly improved the number of headache-free PMPs per patient (0.92 [twice daily], p < 0.0001; 0.69 [once daily], p=0.009) versus 0.42 (placebo). The incidence of severe headache was significantly less with FROVA once daily (44 percent; p=0.007) and twice daily (40 percent; p=0.0003) compared with placebo (58 percent), lowering the ratio of severe to mild migraine from 11:1 with placebo to 4:1 [once daily] and 2:1 [twice daily] with FROVA.

Reductions in migraine symptoms were significant for nausea (twice daily on
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