FDA Approves Satsuma’s STS101 Nasal Powder for Acute Migraine
Approval is based on results from the Phase III ASCEND trial, in which patients using the powder achieved freedom from pain by 2 hours post-treatment in 34.2% of migraine attacks.
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 Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL's novel intranasal drug delivery platform technology. We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems."
According to Satsuma, Atzumi 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. It is also the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform, which combines a proprietary advanced powder and device technology to simplify delivery of DHE.
In the press release, Stewart J. Tepper, MD, vice president of the New England Institute for Neurology and Headache in Stamford, Connecticut, said: "DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages.”
In the Phase III, open-label ASCEND trial, STS101 achieved positive results. In the study, 172 participants treated 1,932 migraine attacks exclusively with STS101. Of all treated attacks, 34.2% experienced freedom from pain by 2 hours post-treatment.2
Satsuma originally announced outcomes from ASCEND in September 2022. In a press release from the time, John Kollins, then president and CEO of Satsuma, said: “The results reported today from this open-label, long-term safety trial in which subjects administered STS101 to treat their migraine attacks for as long as 18 months in a real-world setting, confirm the favorable safety and tolerability profile of STS101 observed to date in more than 1,600 clinical trial participants and provide important safety information for our planned NDA submission. Additionally, the efficacy signals observed with STS101Mk2, including the robust reported rates for freedom-from-pain and freedom-from-MBS by 2 hours post-treatment, are consistent with its demonstrated improved drug delivery performance as compared to STS101Mk1, which incorporated a first-generation nasal delivery device.”
Additional results from the trial showed 53.4% of all treated migraine attacks achieved freedom from most-bothersome-symptom by 2 hours post-treatment. In over 94% of treated attacks, patients did not report using any rescue medications within 48 hours of administering STS101. The nasal powder demonstrated favorable safety and tolerability profiles, consistent with clinical data from the time of the analysis.
“DHE has long been recommended as a first-line option for the acute treatment of migraine, but the currently-available injectable and liquid nasal spray dosage forms have significant drawbacks that result in limited prescribing, utilization and acceptance among patients.The totality of data generated to date with STS101 point to its potential to transform the paradigm for the acute treatment of migraine attacks,” Alan M. Rapoport, MD, professor of neurology at UCLA and former president of the International Headache Society, said in the press release.
References
1. Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine. News release. Satsuma. April 30, 2025. Accessed May 1, 2025. https://www.prnewswire.com/news-releases/satsuma-pharmaceuticals-announces-us-fda-approval-for-atzumi-dihydroergotamine-nasal-powder-for-the-acute-treatment-of-migraine-302443234.html
2. Satsuma Pharmaceuticals Announces Positive Results from the Ongoing STS101 ASCEND Phase 3 Open-label, Long-term Safety Trial. News release. Satsuma. September 22, 2022. Accessed May 1, 2025. https://www.biospace.com/satsuma-pharmaceuticals-announces-positive-results-from-the-ongoing-sts101-ascend-phase-3-open-label-long-term-safety-trial
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