STS101 FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 24, 2024.
FDA Approved: No
Brand name: STS101
Generic name: dihydroergotamine mesylate
Company: Satsuma Pharmaceuticals, Inc.
Treatment for: Migraine
STS101 (dihydroergotamine mesylate) is a proprietary nasal powder formulation of the ergotamine derivative dihydroergotamine mesylate in development for the acute treatment of migraine.
- Dihydroergotamine mesylate is a well established migraine treatment with more than 70 years of therapeutic use. It is thought to work in the treatment of migraine through agonist effects at 5-HT1D receptors.
- Dihydroergotamine mesylate is currently FDA approved in injectable and liquid nasal spray dosage forms.
- STS101 is a nasal powder formulation that is designed to be easy-to-carry, and quick and easy to self-administer. It is rapid acting, and delivers optimal drug plasma levels that are high enough for robust efficacy, and below those levels associated with adverse events such as nausea and vomiting.
- On January 18, 2024, it was announced that Satsuma Pharmaceuticals, Inc. had received a Complete Response Letter (CRL) from the FDA in response to the New Drug Application (NDA) for STS101. The FDA indicated in the CRL that it had completed its review of the NDA and determined that it cannot be approved in its present form. The principal reasons described in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations.
Development timeline for STS101
Further information
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