FDA

DHE nasal powder OK’d for acute migraine

May 6, 2025

Brand name: Atzumi

Generic name: dihydroergotamine mesylate

Manufacturer: Satsuma Pharmaceuticals

Approval date: April 30, 2025

FDA approved Atzumi (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura in adults.

Efficacy

Approval was based on data from two clinical studies: a phase 1 pharmacokinetics study (NCT03874832) and the phase 3 open-label ASCEND trial (NCT04406649) that assessed the long-term safety of the product. The nasal powder demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine.

Safety

The most common adverse reactions reported (incidence ≥1%) were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.

Recommended dose

The recommended dosage of Atzumi is 5.2 mg (the contents of one nasal device) administered into one nostril. The dose may be repeated, if needed, a minimum of one hour after the first dose. The maximum dose in a 24-hour period is 10.4 mg (two doses of Atzumi 5.2 mg).

Sources:

Atzumi (dihydroergotamine nasal powder) [package insert]. Satsuma Pharmaceuticals. https://www.satsumarx.com/wp-content/uploads/2025/04/Atzumi-101-US-PI-1.pdf Revised April 2025. Accessed May 5, 2025.

Satsuma Pharmaceuticals announces US FDA approval for Atzumi™ (dihydroergotamine) nasal powder for the acute treatment of migraine. [News release]. 2025. https://investors.satsumarx.com/2025-04-30-Satsuma-Pharmaceuticals-Announces-U-S-FDA-Approval-for-Atzumi-TM-Dihydroergotamine-Nasal-Powder-for-the-Acute-Treatment-of-Migraine