Satsuma Pharmaceuticals, Inc. announced that its 505(b)(2) new drug application (NDA) for STS101, a novel and investigational therapeutic product candidate for the acute treatment of migraine, has been accepted for review by the FDA. Satsuma's STS101 NDA is supported primarily by clinical trials results from the Phase 1 comparative pharmacokinetic and safety trial of STS101 completed in June 2021 and the STS101 ASCEND Phase 3 long-term, open-label safety trial in which 446 subjects treated more than 9,000 migraine attacks with more than 10,500 doses of STS101 for up to 18 months. Although not required for approval based on Satsuma's communications with the FDA, results from the 1,600-subject STS101 SUMMIT Phase 3 double-blind, placebo-controlled efficacy trial are also included in the NDA.

Satsuma announced topline SUMMIT trial results in November 2022 and subsequently announced further results in December 2022. Although STS101 demonstrated numerical, but not statistical significance on SUMMIT trial primary outcome measures (% of subjects free from pain and % of subjects free from most-bothersome-symptom1 at two hours post-dose), STS101 did demonstrate robust and sustained effects (p<0.001) on those endpoints at all post-dose timepoints after two hours (3, 4, 6, 12, 24 and 48 hours). STS101 also demonstrated robust and sustained antimigraine effects across numerous secondary endpoints considered relevant and recommended for assessment in efficacy trials by the FDA in its current industry guidance document and/or the International Headache Society's guidelines for controlled trials of acute treatment of migraine attacks.