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GlobeNewswire·

Satsuma Pharmaceuticals Announces FDA Acceptance of 505(b)(2) NDA for STS101, a Novel and Investigational Dihydroergotamine (DHE) Nasal Powder Product for the Acute Treatment of Migraine

January 2024 PDUFA date expectedIf approved, STS101 would become the only DHE product evaluated in a randomized, placebo-controlled trial (the SUMMIT trial) against modern outcome measures recommended by both the U.S.