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. 

Source: MEDspace