Dihydroergotamine Intranasal Powder for Acute Migraine Treatment

Abstract

Objective:

To describe the properties of a newly approved intranasal powder formulation of dihydroergotamine (DHE) for the acute treatment of migraine headaches.

Data Sources:

A literature search of MEDLINE was performed without date range exclusions using the search terms dihydroergotamine [title] and intranasal powder. Additional articles were identified from review of clinical trial bibliographies and product monographs.

Study Selection and Data Abstraction:

Four English-language articles were identified for analysis of this product, with no date exclusion criteria.

Data Synthesis:

Two phase 1 studies compared DHE intranasal powder with DHE nasal spray or intramuscular injection. At the approved dose, the authors found the intranasal powder to have a C_max of 1870 to 2230 pg/mL, a T_max of roughly 0.5 hours, and a t_1/2 of 12.0 hours. The phase 3 study was open-label and assessed safety across 12 months of use. It yielded expected adverse events, mostly mild to moderate in intensity. In an exploratory efficacy assessment, pain freedom was noted in 12.7%, 36.6%, and 67.1% at 1, 2, and 4 hours post-DHE intranasal powder dose.

Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs:

The intranasal powder has no trials to date comparing tolerability or efficacy against other abortive migraine agents. Thus, other drug classes, such as triptans with or without analgesics, remain preferred.

Conclusions:

The design and pharmacokinetic properties of DHE intranasal powder appear to offer advantages over other DHE dosage forms, but current data do not support its use as a first-line agent for the treatment of migraine headaches.