Satsuma Pharmaceuticals, Inc.

STS101, a nasal powder formulation of dihydroergotamine mesylate by Satsuma Pharmaceuticals, is under FDA review for migraine treatment. It aims for easy self-administration, rapid action, and optimal efficacy with minimal adverse effects. Despite its established therapeutic use, STS101's FDA approval status remains pending as of Dec 4, 2024.

Satsuma Pharmaceuticals' resubmitted NDA for STS101, a nasal DHE formulation for migraine treatment, accepted by FDA with a decision expected by April 30, 2025. STS101 offers rapid migraine relief through a proprietary nasal device. Satsuma, a SNBL subsidiary, focuses on innovative migraine treatments, while SNBL, a leading CRO, advances drug delivery technologies and community well-being.

Satsuma Pharmaceuticals and SNBL announced FDA's acceptance of STS101 resubmission for migraine treatment, with a PDUFA date of April 30, 2025. STS101, a nasal powder formulation of dihydroergotamine, aims to offer quick, convenient self-administration for acute migraine relief.

Satsuma Pharmaceuticals and SNBL announced FDA's acceptance of a resubmitted NDA for STS101, a nasal powder for migraine treatment, with a PDUFA date of April 30, 2025. STS101 aims to offer quick, convenient self-administration for migraine sufferers, targeting a U.S. market exceeding $1.0 billion.

Satsuma Pharmaceuticals and SNBL resubmitted the NDA for STS101, a nasal powder for migraine treatment, addressing FDA's CRL comments on formulation without needing new clinical trials. STS101 aims to offer quick, convenient migraine relief with fast DHE absorption and sustained plasma levels.

STS101, a novel nasal powder for migraine treatment, showed a favorable safety profile and rapid symptom relief in the ASCEND Phase 3 trial. It was well tolerated, with 37% achieving pain freedom and 54% symptom freedom at 2 hours, sustaining benefits over 48 hours. Satsuma Pharmaceuticals seeks FDA approval for STS101.