Vernalis files sNDA for Frova to treat menstrual migraines

By Lisa Kerner

Charlotte, N.C., Sept. 20 - The Food and Drug Administration accepted Vernalis plc's supplemental New Drug Application for Frova (frovatriptan succinate) 2.5 mg tablets for the short-term (six days per month) prevention of menstrual migraine.

To support its sNDA application, the Winnersh, U.K.-based biopharmaceutical company used data from four studies, including two phase 3 studies, examining the efficacy and safety of once- and twice-daily dose regimens of Frova and a 12-month open-label safety study evaluating a six-day dosing regimen.

The review completion date, or PDUFA date, is May 19, 2007, according to a company news release.

Frova is already FDA-approved for acute treatment of migraine with or without aura in adults.

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