Seattle, WA – May 9, 2025 – Seattle Clinical Research Center (SCRC) is proud to share that a new treatment for migraine—Atzumi™ (dihydroergotamine) nasal powder—has been approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adults. SCRC was one of the clinical trial sites for the pivotal Phase III ASCEND study, which evaluated the long-term safety and tolerability of Atzumi in adults living with migraine.
Developed by Satsuma Pharmaceuticals, Atzumi is the first and only DHE (dihydroergotamine) nasal powder to receive FDA approval. Designed for ease of use and portability, Atzumi offers a new delivery method for a time-tested medication that has been used to treat migraine since the 1940s. The product utilizes Satsuma’s proprietary SMART (Simple Muco-Adhesive Release Technology) platform, combining an advanced powder formulation with a user-friendly device to simplify DHE delivery.
Unlike injectable or liquid nasal spray forms of DHE—which can be inconvenient or poorly tolerated by some patients—Atzumi provides a needle-free alternative that achieves rapid and sustained absorption with low variability. This makes it a particularly important option for individuals who need effective migraine relief even later in an attack.
Migraine affects an estimated 40 million Americans and is recognized as the second leading cause of disability worldwide. Its symptoms—severe headache, nausea, sensitivity to light and sound—can significantly impact a person’s quality of life, work, and relationships. For many patients, fast and reliable acute treatment is critical. The approval of Atzumi expands the toolbox for clinicians and patients looking for new options to manage migraine episodes more effectively.
The FDA’s approval of Atzumi was based on results from both a pharmacokinetic Phase 1 study and the ASCEND Phase 3 open-label safety trial. The trials demonstrated favorable outcomes in terms of absorption rate, plasma concentration of DHE, and long-term safety. SCRC’s role in the ASCEND trial underscores the site’s continued commitment to advancing migraine research and bringing novel therapies to those who need them most.
About Seattle Clinical Research Center
Seattle Clinical Research Center is a leading clinical research facility dedicated to advancing healthcare options, seeking medical breakthroughs for humanity, and providing compassionate care to every study participant. Our state-of-the-art research facility, located in the heart of Seattle, specializes in clinical trials for conditions that significantly impact quality of life, including migraine. This milestone serves as a powerful reminder of the value of clinical research and the critical contributions of study participants, who make advancements like this possible.
To learn more about ongoing clinical trials at Seattle Clinical Research Center, visit SeattleCRC.com/Studies.
