Endo submits Frova US sNDA for menstrual migraine

The USA's Endo Pharmaceuticals has submitted a supplemental New Drug Application to the Food and Drug Administration for Frova (frovatriptan succinate) 2.5 mg tablets for the short-term (six days per month) prevention of menstrual migraine. This data submission on this painkiller, originated by UK-based Vernalis, contains the results from previously-reported pivotal Phase III studies that met their primary efficacy endpoints of reduction in incidence of MM.

If the sNDA is approved by the agency, Frova will be the only triptan indicated in the USA for the prevention of MM. Currently, the agent is FDA-approved for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established.

The firms noted that approximately 21 million American women suffer from migraines. Of these, approximately 60%, or 12 million women, are estimated to suffer from menstrual migraines, a condition which can have a serious and debilitating impact. Compared to non-menstrual migraines, menstrual migraines can be more severe and are reported to be longer in duration, often lasting up to three days.