Satsuma Pharmaceuticals, Inc. reported topline results from the STS101 SUMMIT Phase 3 efficacy trial. Although topline data showed numerical differences in favor of STS101 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) (MBS-free) at two hours post-administration, these differences did not achieve statistical significance (p-value <0.05). 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).

In addition, 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 and/or the International Headache Society's guidelines for controlled trials: Proportion of subjects with pain relief at 2 hours post-dose (p=0.0017) and at all timepoints thereafter; Proportion of subjects requiring rescue medication within 24 hours and 48 hours post-treatment (p<0.0001 and p=0.0001, respectively); Proportion of subjects with 24-hour sustained freedom from pain, i.e., the proportion of subjects who reported no headache pain at 2 hours post-dose who remained free from pain at all timepoints through 24 hours (p=0.0479); Consistent with clinical trial experience to date, STS101 demonstrated a favorable safety and tolerability profile in SUMMIT. The only treatment-emergent adverse event reported by more than 5% of SUMMIT subjects who self-administered STS101 was nasal discomfort, reported by 8.3% of subjects. No treatment-related serious adverse events or cardiovascular events occurred.

In addition, Satsuma announced that it does not plan to invest in commercializing STS101 and will actively explore alternatives to maximize value for shareholders, while minimizing cash expenditures. As of October 31, 2022 the company had estimated cash and equivalents $59.4 million.