Satsuma STS101 Migraine Candidate Fails Late-Stage Trial
Satsuma Pharmaceuticals’ STS101 (dihydroergotamine nasal powder) did not pass muster in a phase 3 clinical trial for treatment of acute migraine.
Although STS101 showed numerical differences in favor of the investigational candidate compared to placebo in the co-primary endpoints of freedom from pain and freedom from the most bothersome symptom — such as photophobia, phonophobia and nausea — at two hours post-administration, the differences were not statistically significant, the company said.
STS101 did demonstrate significant effects by three hours post-dose and at all subsequent assessment timepoints — four, six, 12, 24 and 48 hours.
“We believe the results from the STS101 phase 1 pharmacokinetic and ASCEND phase 3 open-label, long-term safety trials will support the STS101 [new drug application] and marketing approval,” said Satsuma CEO John Kollins.
But the company “does not plan to invest in commercializing STS101 and will actively explore alternatives,” he said.
Satsuma Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing a therapeutic product for the acute treatment of migraine. The Company's product candidate, STS101, is a drug-device combination of a dry-powder formulation of dihydroergotamine mesylate (DHE), which is self-administered with a pre-filled, single-use, nasal delivery device. STS101 also incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique.
November 15, 2022
