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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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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…

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Charleston Gazette-Mail broke the news in Charleston, United States on Thursday, May 1, 2025.
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