Despite Trial Failure, Satsuma Says Its Migraine Candidate Has Potential For Approval
- Satsuma Pharmaceuticals Inc provided an update on its STS101 development program and corporate update.
- Further analysis of results from the recently-completed SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine shows differentiating and sustained antimigraine effects on clinically critical secondary endpoints.
- Satsuma believes the results of its STS101 clinical trial program support the planned FDA marketing application filing in Q1 2023 and potential approval.
- The company said there is a compelling rationale, with regulatory precedents, for including a portion of the SUMMIT trial efficacy results in the STS101 prescribing information, despite STS101 not achieving statistical significance versus placebo.
- Consistent with prior guidance, Satsuma remains on track to submit the STS101 NDA in the first quarter of 2023.
- In parallel, the company is working to secure a commercialization partner for STS101.
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