Acceptance for filing indicates recognition by the FDA that the submission is complete and warrants full review of the data needed to assess the safety and efficacy of Frova for the short-term prevention of menstrual migraine.
The FDA is expected to complete its review within ten months from the submission date. Vernalis’ partner, Endo Pharmaceuticals, submitted the application in July 2006.
Frova is already approved by the FDA for the acute treatment of migraine attacks with or without aura in adults.
The sNDA for Frova is supported by 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 Frova, and a 12-month open-label safety study evaluating a six-day dosing regimen of Frova.