The U.S. Food and Drug Administration (FDA) has granted approval to Atzumi™, a dihydroergotamine mesylate (DHE) nasal powder, developed by Satsuma Pharmaceuticals, for the acute treatment of migraine attacks with or without aura in adults.
Atzumi™ is designed using a breath-powered, dry powder delivery system that allows rapid and efficient absorption of DHE through the nasal mucosa. This innovative approach is particularly beneficial during migraine attacks, where nausea and delayed gastric emptying can interfere with the effectiveness of oral medications.
Unlike traditional injectable or intravenous DHE formulations, Atzumi™ provides needle-free, self-administered treatment that is convenient, portable and does not require refrigeration, making it ideal for on-the-go use during the onset of migraine symptoms.
FDA approval is based on robust data from Phase 3 clinical trials, including the STS101-301 study, which showed that Atzumi™ offered statistically significant pain freedom at 2 hours, as well as improvement in key associated symptoms such as photophobia, phonophobia and nausea. The product demonstrated consistent results across multiple attacks, emphasizing reliability in real-world use. The most commonly reported side effects included nasal discomfort, altered taste and mild throat irritation effects generally well tolerated and transient. Importantly, no serious cardiovascular events were reported, aligning with the known safety profile of DHE.
Migraine affects over 39 million people in the United States alone, with many patients reporting inadequate response or intolerance to current therapies. Atzumi™ addresses several unmet needs by combining rapid onset, ease of use and non-oral administration, offering a new level of flexibility for those with unpredictable or severe migraine patterns.
Satsuma Pharmaceuticals plans to commercially launch Atzumi™ later in 2025, with additional patient support programs and educational resources aimed at improving awareness and access.
Disclaimer: The information provided by Medosis Newsroom is intended for general informational purposes only and does not constitute medical advice, diagnosis or treatment recommendations. Always seek the guidance of a qualified healthcare provider with any questions regarding medical condition or medication. The approval information herein is based on regulatory announcements and public sources current as of the date of publication.
