Application Filed for Orally Inhaled Migraine Drug

The FDA has accepted a new drug application for Levadex (dihydroergotamine), an orally inhaled drug for the acute treatment of migraine in adults.

MAP Pharmaceuticals, Inc., announced Wednesday that the FDA had accepted its new drug application for Levadex (dihydroergotamine), an orally inhaled drug designed for the acute treatment of migraine in adults.

The application includes efficacy and safety data from a Phase 3 trial in which more than 475 patients completed six months of treatment and more than 250 patients completed 12 months of treatment. The trial found that, compared with those who took a placebo, patients who took Levadex had greater relief from pain, phonophobia, photophobia, and nausea.

The application also included data evaluating the drug’s pharmacokinetics, its effects on pulmonary artery pressure and cardiac QT interval, and its safety in smokers, non-smokers, and asthmatics.

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MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA for LEVADEX® [Press Release]