The results were from the second of the two successful phase III placebo-controlled clinical trials evaluating the efficacy and safety of Frova in menstrual migraine (MM) prophylaxis.
Women receiving Frova started the six-day regimen two days prior to the onset of their anticipated headache. Starting treatment two days before the expected headache ensures that patients have adequate blood levels at the time they usually start to experience MM, and continuing treatment for six days ensures that they are covered during the whole period when they are likely to experience those headaches. Women in the study had responded poorly to previous acute triptan treatment for MM.
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 2.5mg once a day, Frova 2.5mg twice a day, or placebo.
The study’s primary endpoint was the number of completely headache-free perimenstrual periods (PMPs). Frova therapy significantly improved the number of headache-free PMPs per patient. The incidence of severe headache was significantly less with Frova once daily (44%) and twice daily (40%) compared with placebo (58%).
Endo has submitted a supplemental New Drug Application for Frova 2.5mg tablets for the short-term (six days per month) prevention of MM to the FDA.