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Satsuma STS101 Migraine Candidate Fails Late-Stage Trial

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.

About Satsuma Pharmaceuticals Inc

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


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