SHIN NIPPON BIOMEDICAL LABORATORIES

FDA Accepts Satsuma Pharmaceuticals' NDA for STS101 Migraine Treatment

- The FDA has accepted Satsuma Pharmaceuticals' 505(b)(2) NDA for STS101, a novel nasal powder formulation of dihydroergotamine mesylate (DHE) for acute migraine treatment. - STS101 is designed for easy self-administration and rapid achievement of high drug plasma levels, potentially offering advantages over existing DHE products. - The NDA is supported by Phase 1 and Phase 3 trial results, including the SUMMIT trial, which demonstrated robust and sustained effects on migraine endpoints. - Satsuma Pharmaceuticals is in the process of being acquired by Shin Nippon Biomedical Laboratories, Ltd. (SNBL).