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
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Phase III SELECT-GCA Trial Results Lead to FDA Approval of Rinvoq for Giant Cell Arteritis
April 30th 2025Rinvoq (upadacitinib) becomes the first oral JAK inhibitor approved by the FDA for the treatment of giant cell arteritis in adults, following robust data from the Phase III SELECT-GCA trial demonstrating its efficacy in achieving sustained remission and reducing glucocorticoid exposure.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
