Atzumi FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 4, 2024.

FDA Approved: Yes (First approved April 30, 2025)
Brand name: Atzumi
Generic name: dihydroergotamine mesylate
Dosage form: Nasal Powder
Previous Name: STS101
Company: Satsuma Pharmaceuticals, Inc.
Treatment for: Migraine

Atzumi (dihydroergotamine mesylate) is a nasal powder formulation of the ergotamine derivative dihydroergotamine mesylate for the acute treatment of migraine.

Atzumi is indicated for the acute treatment of migraine with or without aura in adults.
Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura.
Dihydroergotamine mesylate is a well established migraine treatment with more than 70 years of therapeutic use. It is thought to work in the treatment of migraine through agonist effects at 5-HT_1D receptors.
Dihydroergotamine mesylate is currently FDA approved in injectable and liquid nasal spray dosage forms.
Atzumi is a nasal powder formulation that is designed to be easy-to-carry, and quick and easy to self-administer. It is rapid acting, and delivers optimal drug plasma levels that are high enough for robust efficacy, and below those levels associated with adverse events such as nausea and vomiting.

Development timeline for Atzumi

Date	Article
Apr 30, 2025	Approval FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine
Nov 26, 2024	Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura
Oct 30, 2024	Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura
Jan 18, 2024	FDA Issues Complete Response Letter for Satsuma’s STS101
May 18, 2023	Satsuma Pharmaceuticals Announces FDA Acceptance of 505(b)(2) NDA for STS101, a Novel and Investigational Dihydroergotamine (DHE) Nasal Powder Product for the Acute Treatment of Migraine
Jul 28, 2021	Satsuma Pharmaceuticals Announces First Subject Randomized in SUMMIT™, a Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine
Sep 10, 2020	Satsuma Pharmaceuticals Announces Topline Results from EMERGE Phase 3 Trial of STS101 for the Acute Treatment of Migraine

Further information

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