Satsuma Pharmaceuticals Announces Topline Results from SUMMIT Phase 3 Trial of STS101 for the Acute Treatment of Migraine
STS101 was not statistically superior to placebo at two hours post-administration on the co-primary endpoints of freedom from pain and most bothersome symptom STS101 showed superiority (p<0.001) differences versus placebo on freedom from pain and most bothersome symptom at all timepoints after two hours post-administration (3, 4, 6, 12, 24 and 48 hours), as well as on multiple key secondary endpoints, including pain relief at 2 hours post-administration and all timepoints thereafterSTS101 demonstrated a favorable safety and tolerability profile, consistent with clinical trial experience to dateBased on previous interactions with the FDA, Satsuma believes results from the STS101 Phase 1 PK an