Endo expects to file a supplemental new drug application with the FDA in the coming weeks to seek approval for the expanded indication. Frova is currently approved for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established.
Both once and twice-daily dose regimens of Frova demonstrated efficacy, achieving a statistically significant improvement over placebo in the trials primary endpoint of the number of menstrual migraine-free peri-menstrual periods.
“We are delighted to have achieved a positive outcome from this confirmatory efficacy trial with Frova. The women in this study represent a difficult-to-treat population, each having previously failed acute therapy. These results underscore our belief in the potential of Frova,” said Simon Sturge, CEO of Vernalis.