Satsuma Pharmaceuticals and SNBL Announce Publication of Impression of Use and Satisfaction with STS101 (Dihydroergotamine Nasal Powder (Atzumi™)) in Headache
Satsuma Pharmaceuticals (NASDAQ:STSA) announced publication (Nov 5, 2025) of patient impression and use data for STS101/Atzumi from the pivotal Phase 3 ASCEND study.
Key facts: ASCEND enrolled 482 patients, 446 received at least one dose, and subjects used 10,137 doses for up to 18 months. Participants reported STS101 was easy to use and likely to be used because it worked faster and more consistently than their usual meds. Exploratory efficacy endpoints showed rapid freedom from pain and most bothersome symptoms at 2 hours and sustained benefits through 48 hours.
Atzumi is indicated for acute treatment of migraine in adults and carries a boxed warning contraindicating coadministration with strong CYP3A4 inhibitors; common adverse reactions included rhinitis, nausea, altered taste, application site reaction, and dizziness.
Satsuma Pharmaceuticals (NASDAQ:STSA) ha annunciato la pubblicazione (5 novembre 2025) dei dati sull’impressione dei pazienti e sull’uso di STS101/Atzumi dallo studio pivotale di fase 3 ASCEND.
Fatti chiave: ASCEND ha arruolato 482 pazienti, 446 hanno ricevuto almeno una dose e i soggetti hanno usato 10.137 dosi per un periodo massimo di 18 mesi. I partecipanti hanno riferito che STS101 è facile da usare e che è probabile che venga utilizzato perché ha agito più rapidamente e in modo più coerente rispetto ai loro farmaci abituali. Gli endpoint di efficacia esplorativi hanno mostrato un rapido sollievo dal dolore e dai sintomi più fastidiosi entro 2 ore e benefici sostenuti fino a 48 ore.
Atzumi è indicato per il trattamento acuto della cefalea in adulti e comporta un avviso in scatola che contrasta la co-somministrazione con inibitori CYP3A4 forti; gli eventi avversi comuni includevano rinite, nausea, alterazione del gusto, reazione nel sito di applicazione e vertigini.
Satsuma Pharmaceuticals (NASDAQ:STSA) anunció la publicación (5 de noviembre de 2025) de la impresión de los pacientes y datos de uso para STS101/Atzumi del estudio pivotal de fase 3 ASCEND.
Datos clave: ASCEND inscribió a 482 pacientes, 446 recibieron al menos una dosis y los sujetos usaron 10.137 dosis durante hasta 18 meses. Los participantes informaron que STS101 era fácil de usar y probablemente se utilizaría porque funcionó más rápido y de manera más consistente que sus medicamentos habituales. Los puntos de eficacia exploratorios mostraron libertad rápida del dolor y de los síntomas más molestos a las 2 horas y beneficios sostenidos hasta las 48 horas.
Atzumi está indicado para el tratamiento agudo de la mígraña en adultos y conlleva una advertencia en recuadro que contraindica la coadministración con inhibidores fuertes de CYP3A4; las reacciones adversas comunes incluyeron rinorrea, nauseas, alteración del gusto, reacción en el sitio de aplicación y mareos.
Satsuma Pharmaceuticals (NASDAQ:STSA)는 3상 ASCEND 연구의 중요한 페이즈의 환자 인상 및 STS101/Atzumi 사용 데이터의 출판을 발표했습니다(2025년 11월 5일).
주요 사실: ASCEND 연구에는 482명의 환자가 등록되었고, 446가 최소 한 차례 용량을 받았으며 피험자들은 최대 18개월 동안 10,137회 용량을 사용했습니다. 참가자들은 STS101이 사용하기 쉽고, 기존 약보다 더 빨리 작동하고 더 일정하게 작용했기 때문에 사용될 가능성이 높다고 보고했습니다. 탐색적 효능 평가 지표는 2시간 내 통증 및 가장 불편한 증상의 빠른 해소 및 48시간 동안의 지속적인 이점을 보여주었습니다.
Atzumi은 성인 편두통의 급성 치료를 위해 적응되었으며 강한 CYP3A4 억제제와의 병용을 금지하는 상자형 경고가 있습니다; 흔한 부작용으로는 비염, 메스꺼움, 맛 저하, 주사 부위 반응 및 현기증이 포함됩니다.
Satsuma Pharmaceuticals (NASDAQ:STSA) a annoncé la publication (5 novembre 2025) des données d’impression des patients et d’utilisation pour STS101/Atzumi issues de l’étude pivot de phase 3 ASCEND.
Faits clés : ASCEND a accrûté 482 patients, 446 ont reçu au moins une dose, et les sujets ont utilisé 10 137 doses sur une période allant jusqu’à 18 mois. Les participants ont indiqué que STS101 était facile à utiliser et qu’il serait probablement utilisé car il agissait plus rapidement et de manière plus cohérente que leurs médicaments habituels. Les critères d’efficacité exploratoires ont montré une disparition rapide de la douleur et des symptômes les plus gênants à 2 heures et des bénéfices soutenus jusqu’à 48 heures.
Atzumi est indiqué pour le traitement aigu de la migraine chez l’adulte et comporte un avertissement entre crochets indiquant la contremédication de la coadministration avec des inhibiteurs CYP3A4 puissants; les réactions indésirables courantes comprenaient la rhinorrhée, les nausées, les altérations du goût, une réaction au site d’application et des vertiges.
Satsuma Pharmaceuticals (NASDAQ:STSA) kündigte die Veröffentlichung (5. November 2025) von Patienteneinschätzungen und Nutzungsdaten für STS101/Atzumi aus der präskriptiven Phase-3-Studie ASCEND an.
Wichtige Fakten: ASCEND rekrutierte 482 Patienten, 446 erhielten mindestens eine Dosis, und Probanden verwendeten 10.137 Dosen über bis zu 18 Monate. Die Teilnehmer berichteten, dass STS101 einfach zu verwenden ist und wahrscheinlich verwendet wird, weil es schneller wirkt und konsistenter als ihre gewöhnlichen Medikamente. Exploratorische Wirksamkeitsendpunkte zeigten schnelle Freisetzung von Schmerz- und Symptomenfreiheit nach 2 Stunden und dauerhafte Vorteile über 48 Stunden.
Atzumi ist für die akute Behandlung der Migräne bei Erwachsenen vorgesehen und trägt eine Boxed-Warnung, die eine gleichzeitige Verabreichung mit starken CYP3A4-Hemmern kontraindiziert; gängige unerwünschte Reaktionen umfassten Rhinorrhoe, übelkeit, Geschmacksänderung, Reaktion an der Anwendungsstelle und Schwindel.
Satsuma Pharmaceuticals (NASDAQ:STSA) أعلنت عن نشر (5 نوفمبر 2025) بيانات انطباع المرضى واستخدام STS101/Atzumi من الدراسة الحاسمة ASCEND من المرحلة الثالثة.
حقائق رئيسية: قامت ASCEND بتسجيل 482 مريضا، وتلقى 446 جرعة واحدة على الأقل، واستخدم المشاركون 10,137 جرعة لمدة تصل إلى 18 شهراً. أفاد المشاركون أن STS101 سهل الاستخدام ومن المحتمل أن يُستخدم لأنه عمل بشكل أسرع وبشكل أكثر اتساقاً من أدويتهم المعتادة. أظهرت نقاط النهاية الفاعلة الاستكشافية إخلاءً سريعاً من الألم وأعراض الأكثر إزعاجاً خلال ساعتين و فوائد مستمرة حتى 48 ساعة.
Atzumi مخصص لعلاج الصداع النصفي الحاد عند البالغين ويحمل تحذيراً داخل علبة يقيّد التزامن مع مثبطات CYP3A4 القوية؛ تشمل التأثيرات الضارة الشائعة الرنينية (الروتين)، والغثيان، وتغير الطعم، وتفاعل في موضع التطبيق، والدوخة.
- ASCEND enrolled 482 patients
- 446 patients received at least one dose
- Patients used 10,137 doses over up to 18 months
- Exploratory efficacy: freedom from pain and MBS at 2 hours
- Sustained treatment benefits reported through 48 hours
- High patient-reported ease of use and likelihood to reuse
- Contraindicated with strong CYP3A4 inhibitors (risk of peripheral ischemia)
- Not indicated for preventive treatment, hemiplegic migraine, or brainstem aura
- Most common adverse reactions (>1%): rhinitis, nausea, altered taste, application site reaction, dizziness
Insights
Publication of Phase 3 ASCEND impression and exploratory efficacy data supports favorable patient experience and signals clinical activity, but evidence is exploratory and open‑label.
STS101 (Atzumi™) showed that participants rated the product easy to use and reported rapid pain freedom and relief of most bothersome symptoms by
The evidence carries clear limitations: the trial was open‑label and the efficacy endpoints are described as exploratory, which prevents firm efficacy conclusions. Safety information and contraindications for coadministration with strong CYP3A4 inhibitors and specific cardiovascular risks remain prominent in the label and materially affect the eligible patient population.
Watch for subsequent peer‑reviewed reports or randomized controlled data that confirm primary endpoints, regulatory filings, and any postmarketing safety findings; near‑term signals to monitor include formal primary endpoint results, regulatory submissions, and labeling decisions likely to appear within the next 6–18 months.
Results show that participant impression through 12 months of treatment indicate STS101 is perceived as favorable across multiple attributes.
Exploratory Efficacy Endpoints showed that STS101 provided rapid freedom from pain, from most bothersome symptoms at 2 hours and sustained treatment benefits over 48 hours after dosing.
DURHAM, N.C., Nov. 5, 2025 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395) are dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions. STS101 is the only product to combine Satsuma's proprietary SMART™ (Simple MucoAdhesive Release Technology) with an easy-to-use, easy-to carry nasal delivery device.
"We are proud to announce the publication of this important impression and use data from our pivotal Phase 3 ASCEND study, which further reinforce the potential for STS101 to be a unique, well-tolerated treatment that has the potential to deliver rapid and enduring symptom relief for patients with acute migraine," said Ryoichi Nagata, President and CEO of Satsuma, M.D., Ph.D., FFPM. "We were particularly pleased to see that a vast majority of patients reported that STS101 was easy to use."
In this study, most participants considered STS101 easy to use and indicated they would be likely to use the product if it were available because it worked faster and more consistently, enabling them to return to normal more rapidly in comparison to their usual migraine medications.
"I am pleased that the data supported the clinical benefit of STS101 in the acute treatment of migraine with a reliable and easy to use delivery system. This is exciting and important information for people living with migraine who have experienced difficulties with existing therapies and the practitioners who treat them who are in need of new options," said Jessica Ailani, M.D., Neurologist and UCNS certified headache specialist, Washington, DC. "There remains a need for novel non-oral treatment options for subjects with migraine who are often unable to achieve rapid relief with orally administered medications."
The publication can be found here, http://doi.org/10.1111/head.15086.
About the ASCEND Study
ASCEND Study was a pivotal Phase 3 open-label study that evaluated the safety, tolerability, exploratory efficacy, and patient acceptability of STS101. The trial was conducted at 54 sites in the United States and enrolled 482 patients who had a documented diagnosis of migraine with or without aura, with 4 to 12 migraine attacks per month in each of the 3 months prior to the study. In the trial, 446 patients received at least one dose of STS101 and used 10,137 doses of STS101 for up to 18 months.
About Atzumi™
Atzumi™ is a proprietary drug device product incorporating both Satsuma's advanced nasal powder formulation of dihydroergotamine (DHE) administered via its unique nasal delivery device. The product is designed to provide patients with an easy-to-use and easy-to-carry treatment option.
IMPORTANT SAFETY INFORMATION
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Atzumi™ with strong CYP3A4 inhibitors is contraindicated.
Indication
Atzumi™ is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Atzumi™ is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura.
Contraindications
Atzumi™ is not recommended in patients with:
Concomitant use of strong CYP3A4 inhibitors
Ischemic heart disease or coronary artery vasospasm
Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment
Hypersensitivity to ergot alkaloids
Concomitant use of other 5-HT₁ agonists or ergotamine-containing or ergot-type medication within 24 hours
Concomitant use of peripheral and central vasoconstrictors
Warnings and Precautions
Atzumi™ may cause:
Cardiac events: Cardiac events in patients with risk factors of coronary artery diseases: Consider administration of the first dose of Atzumi™ under medical supervision (including the use of an electrocardiogram)
Cerebrovascular events: Cerebrovascular events (e.g., cerebral hemorrhage, subarachnoid hemorrhage, and stroke) have been reported, particularly with dihydroergotamine mesylate injection
Vasospasm/elevated blood pressure: Dihydroergotamine may cause vasospasm or elevation in blood pressure
Medication overuse headache: Detoxification may be necessary
Preterm labor: Advise pregnant women of the risk
Fibrotic complications: Rare cases have been reported following prolonged daily use of dihydroergotamine mesylate. Administration of Atzumi™ should not exceed the dosing guidelines or be used for chronic daily administration
Local irritation: Local irritation has been reported following administration of Atzumi™
Most Common Adverse Reactions
Most common adverse reactions (incidence >
Use in Special Populations
Pregnancy: Available data from published literature indicate an increased risk of preterm delivery with Atzumi™ use during pregnancy.
Lactation: Patients should not breastfeed during treatment with Atzumi™ and for 3 days after the last dose.
Please see the Atzumi™ Full Prescribing Information, including Boxed Warning and Medication Guide.
The risk information provided here is not comprehensive. The FDA-approved product labeling can be found at www.satsumarx.com. You can also call 1-888-273-2480 for additional information.
About Satsuma Pharmaceuticals
Satsuma Pharmaceuticals Inc., a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company headquartered in Research Triangle Park, North Carolina. Since its inception in 2016, Satsuma has focused on combining great science, cutting-edge technology and proven drug therapies to create improved therapeutic products that address the significant unmet needs of patients. Satsuma's team has extensive experience successfully developing, manufacturing and commercializing pharmaceutical products within both large and small companies, and we have particular expertise in the area of drug-device combination products delivered via inhalation. For further information, please visit www.satsumarx.com.
About SNBL
Shin Nippon Biomedical Laboratories, Ltd. ("SNBL") (TSE:2395) is a listed nonclinical contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. Based on its corporate philosophy of "Committed to the environment, life, and people", and with a proven track record of accomplishment as the oldest and most established Japanese nonclinical CRO, SNBL is proud to offer a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL's Translational Research business engages in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. For further information, please visit https://en.snbl.com/.
Medical information
This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
Inquiries:
Satsuma Pharmaceuticals, Inc.
E-mail: info@satsumarx.com
Website: www.satsumarx.com
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