SHIN NIPPON BIOMEDICAL LABORATORIES, LTD.

FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment

7 months ago

• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment. • The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s. • STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations. • The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.

FDA Accepts Satsuma Pharmaceuticals' NDA for STS101 Migraine Treatment

2 years ago

• 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).