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# Satsuma Plans Migraine NDA After Data Miss
- URL: https://www.fdaweb.com/satsuma-plans-migraine-nda-after-data-miss/
- Published: 2022-11-14T12:00:00.000Z
- Updated: 2026-09-14T18:06:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153194

Satsuma Pharmaceuticals says topline results from the STS101 SUMMIT Phase 3 efficacy trial showed numerical differences in favor of its migraine drug STS101 5.2 mg versus placebo, but they did not achieve statistical significance. It says the favorable differences were related to the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (MBS) — from among photophobia, phonophobia and nausea — at two hours post-administration. “STS101 did, however, demonstrate significant effects on both freedom-from-pain and MBS-free endpoints by three hours post-dose and at all subsequent timepoints at which efficacy was assessed (4, 6, 12, 24 and 48 hours),” it says.

“In addition,” it says, “STS101 was statistically superior to placebo on multiple key secondary endpoints considered clinically relevant and recommended for assessment in acute-treatment-of-migraine efficacy trials by the U.S. Food and Drug Administration (FDA) in its current industry guidance document…”

While “surprised and disappointed” about the miss on the primary endpoints, the company says that based on interactions with FDA it still believes the results and other data from earlier trials will support an NDA approval. “A large proportion of people with migraine do not achieve sufficient and sustained relief with current treatments, and we believe that in total, the data from the STS101 clinical program, in which more than 1,600 subjects treated more than 8,500 migraine attacks with more than 10,000 doses of STS101, demonstrate that STS101 has a differentiated profile and may address the unmet needs of many patients,” it explains.