Nasal Powder for Acute Migraine Gets FDA Nod
- Satsuma Pharmaceuticals announced on April 30, 2025 in Durham, North Carolina that the FDA approved Atzumi, a nasal powder containing dihydroergotamine for acute migraine treatment in adults.
- This FDA approval followed two clinical studies demonstrating Atzumi's fast absorption, rapid high plasma DHE levels, and safety in migraine patients, continuing the long history of DHE use since 1946.
- Atzumi is the only DHE nasal powder utilizing SNBL's SMART delivery platform, offering an easy-to-use device approved specifically for acute migraine treatment but not for prevention or use with certain medical conditions.
- Common adverse reactions include rhinitis, nausea, altered taste, dizziness, and application site reactions, while cardiac and cerebrovascular risks require medical supervision in at-risk patients.
- Satsuma’s CEO Dr. Ryoichi Nagata and Dr. Stewart J. Tepper highlighted Atzumi’s milestone approval and unique clinical role, expecting it to improve quality of life for millions of migraine sufferers.
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Nasal Powder for Acute Migraine Gets FDA Nod
(MedPage Today) -- The FDA approved dihydroergotamine (DHE) nasal powder (Atzumi) 5.2 mg to treat acute migraine with or without aura in adults, Satsuma Pharmaceuticals announced Wednesday. The product is the only DHE nasal powder for acute migraine...

Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine
Atzumi™ (dihydroergotamine(DHE)) nasal powder is the first and only DHE nasal powder for the acute treatment of migraine with or without aura in adults in an easy-to-use, easy-to-carry device.Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive…
FDA Approves Satsuma’s STS101 Nasal Powder For Acute Migraine - Data Intelligence
Image Credit: © yodiyim – stock.adobe.com The FDA has approved Satsuma’s STS101 dihydroergotamine (DHE) nasal powder under the name of Atzumi as a new treatment for adults with acute migraine, with or without aura. The approval is based on positive results from the Phase III ASCEND clinical trial as well as a Phase I pharmacokinetic study.1 In a press release, Ryoichi Nagata, MD, PhD, FFPM, president and CEO of Satsuma, said: “The approval of At…
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