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# Satsuma Pharma NDA Resubmission for Migraine Drug
- URL: https://www.fdaweb.com/satsuma-pharma-nda-resubmission-for-migraine-drug/
- Published: 2024-11-26T12:00:00.000Z
- Updated: 2026-09-14T14:48:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158266

FDA has accepted for review a Satsuma Pharmaceuticals NDA resubmission for STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura. In January, FDA issued Satsuma a complete response letter on the original NDA due to chemistry, manufacturing, and controls considerations, according to the company. The agency set a user fee review action target date of 4/30/2025.

STS101 is described as a proprietary drug-device that incorporates Satsuma’s nasal powder formulation of dihydroergotamine (DHE) administered via a nasal delivery device. “The product is designed to provide patients and 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.