Atzumi is an FDA-approved dihydroergotamine nasal powder for the acute treatment of migraine, delivered via a proprietary intranasal system that has been shown to achieve rapid and sustained plasma concentrations.
Developed by Satsuma Pharmaceuticals, a subsidiary of Shin Nippon Biomedical Laboratories, Ltd., Atzumi is the first dihydroergotamine (DHE) nasal powder to be approved in the U.S. It is also the only product to utilize the Simple MucoAdhesive Release Technology platform. This drug-device combination is designed to simplify DHE delivery using an advanced powder formulation and intranasal device.
FDA approval was supported by data from a phase I pharmacokinetic study and the ASCEND phase III long-term, open-label safety trial. These studies demonstrated that Atzumi achieved rapid absorption and sustained plasma concentrations of DHE with low interpatient variability. The most common adverse events (incidence of more than 1%) included rhinitis, nausea, altered taste, local application site reactions, dizziness, somnolence, pharyngitis, vomiting, and diarrhea.
DHE has been used since 1946 and is endorsed in clinical guidelines as a first-line treatment for acute migraine. However, limitations with current injectable and liquid nasal spray formulations—such as invasiveness and inconsistent efficacy—have hindered broader clinical use. Atzumi aims to address these limitations through a more convenient and portable delivery mechanism.
The labeling for Atzumi includes a boxed warning regarding serious and potentially life-threatening peripheral ischemia when coadministered with strong CYP3A4 inhibitors. Atzumi is contraindicated in patients with ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, sepsis, recent vascular surgery, or severe hepatic or renal impairment. Concomitant use of other ergot derivatives or 5-HT₁ agonists within 24 hours is also not recommended. Further warnings include the risk of cardiac or cerebrovascular events, medication overuse headache, vasospasm, preterm labor, and fibrotic complications associated with prolonged daily use.
Atzumi is not indicated for the prevention of migraine or for hemiplegic migraine or migraine with brainstem aura. Physicians are advised to review the full prescribing information, including the boxed warning and medication guide, which is available at www.satsumarx.com.
Source: Satsuma Pharmaceuticals