FDA requests extension for Frova sNDA

The US Food and Drug Administration has requested an extension of the August 19 review date of the supplemental New Drug Application for Frova (frovatriptan succinate) 2.5mg tablets for the additional indication of short-term (six days) prevention of menstrual migraine.

The FDA indicated that it will provide a revised timeline to the drug's developers, USA-based Endo Pharmaceuticals and the drug's UK originator, Vernalis. Until the companies receive this information from the agency, they intend to continue with their existing commercial plan. They noted that the FDA has not currently requested any additional information or trial data. The selective 5-HT1B/1D receptor agonist is approved in the USA and Europe as an acute oral treatment for migraine headache. In May 2006, Vernalis completed the final Phase III efficacy study in order to expand the label for short-term prevention of menstrual migraine. The sNDA was accepted September 2006.