Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company, has submitted, to the US Food and Drug Administration (FDA), a supplemental New Drug Application (sNDA) for Frova (frovatriptan succinate) 2.5 mg tablets for the short-term (six days per month) prevention of menstrual migraine (MM). This submission contains data from previously reported pivotal phase III studies, which met their primary efficacy endpoints of reduction in incidence in MM.

If the sNDA is approved by the FDA, Frova will be the only that triptan, that indicated in the US, for the prevention of MM. Currently Frova 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.

Approximately 21 million American women suffer from migraines. Of these female migraineurs, approximately 60 per cent, 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.

"Doctors and patients need to understand that menstrual migraine differs from other kinds of migraines. These differences need to be taken into consideration in order for the condition to be treated appropriately," stated Stephen Silberstein, MD, prof. of neurology at the Jefferson Medical College of Thomas Jefferson University, director of the Jefferson Headache Centre and lead investigator, of the initial efficacy study of Frova, for the short-term prevention of menstrual migraine. "The predictable nature of menstrual migraine supports the future use of preventative therapy for this disabling condition."

"Menstrual migraines disrupt the lives of millions of women, but currently no triptan is approved to prevent them," commented, Peter A. Lankau, president and CEO of Endo, which markets Frova in the US, "If approved. Frova would provide a novel treatment approach to address this unmet medical need. We are pleased to be submitting this sNDA for Frova to the FDA and will work closely with the Agency throughout the review process."

Simon Sturge, CEO of Vernalis, stated, "The data confirm the potential of Frova for the prevention of menstrual migraine. Short-term prevention could be a major benefit for women who do not respond well to acute treatment. We continue to be impressed by the therapeutic potential of Frova."

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 MM, a pharmacokinetics and tolerability study of once- and twice-daily dosing of Frova, and a 12-month open-label safety study evaluating a six-day dosing regimen of Frova in 525 women.