FDA TO EXTEND REVIEW TIME FOR ENDO, VERNALIS' FROVA SNDA

Endo Pharmaceuticals and Vernalis announced that the FDA has informed the companies it will require an additional three months to review the previously submitted supplemental new drug application (sNDA) for Frova 2.5-mg tablets for the short-term prevention of menstrual migraine.

The agency now anticipates completing its review of this application by Aug. 19. The companies said that the FDA's request relates solely to the presentation of the data and that no additional data has been requested.

The Frova (frovatriptan succinate) sNDA included data from four studies, including: two Phase III studies examining the efficacy and safety of once- and twice-daily dose regimens of Frova in the short-term prevention of menstrual migraine; a pharmacokinetics and tolerability study of once- and twice-daily dosing of Frova; and a 12-month, open-label safety study evaluating a six-day dosing regimen of Frova in 525 women.