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news.Endo Pharmaceuticals has submitted a supplemental new drug application to the FDA for its Vernalis co-marketed migraine drug Frova, seeking approval for the short-term prevention of menstrual migraine.
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The submission contains data from previously reported pivotal phase III studies that met their primary efficacy endpoints of reduction in incidence in menstrual migraine.
If the supplemental new drug application (sNDA) is approved by the FDA, Frova will be the only triptan indicated in the US for the prevention of MM. The drug is currently only approved in the US for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established.
“Menstrual migraines disrupt the lives of millions of women, but currently no triptan is approved to prevent them,” noted Peter 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.”
“Doctors and patients need to understand that menstrual migraine differs from other kinds of migraines,” added Dr Stephen Silberstein, professor of neurology at the Jefferson Medical College of Thomas Jefferson University. “The predictable nature of menstrual migraine supports the future use of preventative therapy for this disabling condition.”