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Dihydroergotamine Inhalation Aerosol for the Treatment of Migraine: Insights from Pharmaceutical and Clinical Development

Kellerman DJ, Armer TA, Borland SW, Nelson TS.

RDD Europe 2013. Volume 1, 2013: 35-46.

Abstract:

This article describes the development of MAP0004, an orally inhaled formulation of dihydroergotamine (DHE) intended for the systemic treatment of migraine. Key milestones in this program include the development of a stable formulation of DHE and incorporation of that formulation into a breath-synchronized metered dose inhaler. Human factors considerations, definitive efficacy and short-term safety assessments in subjects with migraine were important during the pharmaceutical and clinical development. Assessments of short- and long-term pulmonary safety of the product in the clinic and the outpatient setting are also presented.