NDA-MAP Pharmaceuticals, Inc Levadex (dihydroergotamine) Oral Inhalation

2 05 2013

New Drug Approvals

Dihydroergotamine

Levadex (dihydroergotamine) Oral Inhalation

MAP Pharmaceuticals, Inc.
Treatment for: Migraine

Levadex (dihydroergotamine) is an investigational orally inhaled migraine therapy.

Dihydroergotamine (/daɪˌhaɪdroʊ.ɜrˈɡɒtəmiːn/ dy-HY-droh-ur-GOT-ə-meen; brand names D.H.E. 45 and Migranal) is an ergot alkaloid used to treat migraines. It is a derivative of ergotamine. It is administered as a nasal spray or injection and has an efficacy similar to that of sumatriptan. Nausea is a common side effect.

It has similar actions to the triptans, acting as an agonist to the serotonin 5-HT(1D) receptors and causing vasoconstriction of the intracranial blood vessels, but also interacts centrally with dopamine and adrenergic receptors. It can be used to treat acute intractable headache or withdrawal from analgesics.

 

Dihydroergotamine (DHE) is a semi-synthetic form of ergotamine approved in the US in 1946. Oral bioavailability is poor and it is not available in oral form in the US. DHE…

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