MAP Pharma files NDA with US regulator for Levadex in migraine

31 May 2011

MAP Pharmaceuticals (Nasdaq: MAPP) has submitted a New Drug Application to the US Food and Drug Administration for Levadex, its orally inhaled migraine drug, which contains a novel formulation of dihydroergotamine (DHE), for the potential acute treatment of migraine in adults.

According to the National Headache Foundation, approximately 30 million people in the USA suffer from migraine, a debilitating neurological disorder. Common symptoms of migraine include recurrent headaches, nausea, phonophobia (sensitivity to sound) and photophobia (sensitivity to light).

Levadex is the subject of a licensing agreement for US marketing rights with Allergan (NYSE: AGN), which paid an upfront $60 million and is set to pay as much as 97 million in additional payments upon meeting certain regulatory milestones associated with the initial indication to MAP (The Pharma Letter February 2).

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