Satsuma Migraine Resubmitted NDA Approved

FDA has approved a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. The NDA was resubmitted 11/2024 after addressing chemistry, manufacturing, and controls considerations cited in a 1/2024 complete response letter, according to the company.

Atzumi is described as a proprietary drug-device that incorporates Satsuma’s nasal powder formulation of DHE administered through a nasal delivery device. “The product is designed to provide patients an easy-to-use and easy-to-carry treatment option,” the company says.

The NDA was based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), “which 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,” Satsuma says.