Satsuma craters as migraine drug fails in Phase III trial

Clinical-stage biopharma company Satsuma Pharmaceuticals (Nasdaq: STSA) on Monday revealed that its experimental lead treatment for acute migraine headaches failed to meet the main goals of a late-stage trial, sending its shares plunging 83% to $0.68.

Th US company reported top-line results from the STS101 SUMMIT Phase III efficacy trial of STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine.

Although top-line data showed numerical differences in favor of STS101 5.2mg 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).