Satsuma Pharmaceuticals, Inc. and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd, announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. 

Atzumi was previously known as STS101.

“The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL’s novel intranasal drug delivery platform technology,” said Dr. Ryoichi Nagata, President and CEO of Satsuma. “We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems.”

Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform, which combines a proprietary advanced powder and device technology to simplify the delivery of DHE.

In clinical studies, Atzumi administration provided rapid and sustained DHE concentrations with low variability.

“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. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages”, said Dr. Stewart J. Tepper, M.D., Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut.