Atzumi FDA Approval History
Last updated by Judith Stewart, BPharm on May 4, 2025.
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 (DHE) is thought to work in the treatment of migraine through agonist effects at 5-HT1D receptors.
- Dihydroergotamine mesylate is a well established migraine treatment with more than 70 years of therapeutic use, and has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine. It has been approved in injectable and liquid nasal spray dosage forms under multiple brand names:
- D.H.E. 45 (dihydroergotamine mesylate) injection (1946 - now discontinued; generic available)
- Migranal (dihydroergotamine mesylate) nasal spray (1997)
- Trudhesa (dihydroergotamine mesylate) nasal spray (2021)
- Atzumi (dihydroergotamine mesylate) nasal powder (2025)
Atzumi utilizes the SMART (Simple MucoAdhesive Release Technology) platform which combines a proprietary advanced powder and device technology to simplify delivery of DHE. It is rapid acting, and delivers optimal drug plasma levels in a formulation that is easy-to-carry, and quick and easy to self-administer. - FDA approval of Atzumi was based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), which 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.
- Atzumi is administered into one nostril by squeezing the device three separate times. The dose may be repeated, if needed, a minimum of 1 hour after the first dose. The maximum dose in a 24-hour period is 10.4 mg (two doses of Atzumi 5.2 mg). The safety of taking more than 4 doses within a 7-day period or 12 doses within a 30-day period has not been established.
- Atzumi comes with a Boxed Warning for serious and/or life-threatening peripheral ischemia associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Warnings and precautions include myocardial Ischemia and/or infarction and other cardiac adverse reactions and fatalities; cerebrovascular adverse reactions and fatalities; other vasospasm related adverse reactions; medication overuse headache; risk of preterm labor in pregnant women; fibrotic complications; and local irritation.
- Common adverse reactions (incidence > 1%) include rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.
Development timeline for Atzumi
Further information
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