Vernalis/Endo Pharma withdraw Frova sNDA

UK drugmaker Vernalis says that its US development partner Endo Pharmaceuticals has notified the Food and Drug Administration of the withdrawal of a supplemental New Drug Application without prejudice to refiling for migraine drug Frova (frovatriptan succinate) 2.5 mg tablets. The sNDA was for the extra indication of short-term (six days per month) prevention of menstrual migraine. The firms are continuing to evaluate Frova's potential for this indication and other related indications and Vernalis noted that its recently announced program of cutbacks (Marketletter February 25) is based on the assumption that, for the immediate future, Frova would only be approved for the acute treatment of migraine.