What Newly Approved STS101 Brings to Migraine Treatment Landscape: Stewart Tepper, MD

WATCH TIME: 7 minutes

"DHE may take longer to work than triptans, but at 24 hours, it’s the tortoise that wins—with fewer recurrences and higher sustained responses."

Migraine, a neurological disease, affects more than 1 billion individuals each year across the world, and is one of the most common neurologic disorders, with a high prevalence and morbidity, especially among young adults and females. The therapeutic landscape for migraine has expanded significantly in recent years, with a handful of notable approvals, including Satsuma’s STS101, the latest to reach market.

Branded as Atzumi, the treatment is indicated for patients with acute migraine with or without aura, and is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. STS101, delivered through a specialized, optimized device, was approved based on several studies, including the phase 3 ASCEND (NCT04406649) and SUMMIT (NCT04406649) trials. In SUMMIT, the agent demonstrated a numerical, but not statistically significant difference vs placebo on the coprimary end points of freedom of pain and freedom from the most bothersome symptom at 2 hours post dose.^1,2

Following the approval, NeurologyLive^® sat down with migraine expert Stewart Tepper, MD, to discuss the significance of this latest addition and the history behind DHE treatments for migraine. Tepper, a professor of neurology at the Geisel School of Medicine at Dartmouth, discussed, detailed the clinical role of DHE, emphasizing its unique ability to reverse migraines even after central sensitization. He also spoke on the small, unique differences with STS101 in comparison to older options like Migranal and Trudhesa. Furthermore, Tepper, who also serves as the vice president of the New England Institute for Neurology and Headache, gave context on the clinical trials supporting STS101’s approval, including the notable safety data observed in ASCEND.

REFERENCES
1. Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine. News Release. Published April 30, 2025. Accessed June 23, 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
2. Satsuma Pharmaceuticals announces positive results from the ongoing STS101 ASCEND phase 3 open-label, long-term safety trial. News release. September 20, 2022. Accessed June 23, 2025. https://www.biospace.com/article/releases/satsuma-pharmaceuticals-announces-positive-results-from-the-ongoing-sts101-ascend-phase-3-open-label-long-term-safety-trial/