, 2025-05-05 14:32:00
The US Food and Drug Administration (FDA) has approved dihydroergotamine (DHE) nasal powder (Atzumi, Satsuma Pharmaceuticals Inc) for the acute treatment of migraine with or without aura in adults
Atzumi (previously STS101) is the “first and only” product utilizing the Simple MucoAdhesive Release Technology (SMART) platform, which combines a proprietary advanced powder and device technology to simplify delivery of DHE, the company said in a news release announcing approval.
“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,” Stewart J. Tepper, MD, vice president, New England Institute for Neurology and Headache, Stamford, Connecticut, said in the release.
“The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages,” Tepper added.
The FDA approved Atzumi based on two clinical studies — the phase 1 pharmacokinetics trial and the phase 3 ASCEND open-label, long-term safety trial, which Tepper led.
The ASCEND study enrolled adults with a ≥ 1 year history of migraine with or without aura and 4-12 migraine attacks per month and < 15 headache days per month in each of the 3 months prior to screening.
The study demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine.
Treatment with DHE nasal powder was associated with rapid onset of freedom from pain (37%, 67%, and 86% of treated attacks 2, 4, and 24 hours after dosing, respectively), freedom from most bothersome symptoms (54%, 80%, and 91%), and headache relief (67%, 89%, and 94%).
Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine, or migraine with brainstem aura. Complete prescribing information is available online.
