Satsuma Pharmaceuticals announces topline results from EMERGE phase III trial of STS 101 nasal powder for the acute treatment of migraine.

Satsuma Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company, announced topline results from its Phase III EMERGE efficacy trial of STS 101 (dihydroergotamine (DHE) nasal) powder as an acute treatment for migraine. Although topline data showed numerical differences in favor of STS 101 3.9 mg and 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) at two hours post-administration, these differences did not achieve statistical significance for either dosage strength. Both dosage strengths of STS 101 did, however, demonstrate significant effects on both freedom from pain and most bothersome symptom by three hours post-dose and later time points. Both STS 101 dosage strengths were well-tolerated in the EMERGE trial, with low adverse event rates and no serious adverse events reported. Further analysis of EMERGE trial data is ongoing, and Satsuma expects to provide a more detailed update on its business plans after these analyses are completed.