Satsuma Pharmaceuticals announced that it has resubmitted its NDA for STS101 intranasal dry powder dihydroergotamine for the acute treatment of migraine with or without aura. The company initially submitted the NDA in March 2023 even though the Phase 3 SUMMIT trial of STS101 failed to meet its primary endpoints.
In January 2024, the FDA issued a CRL to the application in January 2024. According to Satsuma, the CRL did not request additional clinical data and cited only CMC issues, which the company now says it believes that it has addressed.
Satsuma President and CEO Ryoichi Nagata commented, “The resubmission of the STS101 NDA resubmission is a critical step in our mission to bring this unique and new therapy to patients experiencing migraine who often have inadequate treatment options.”
Read the Satsuma Pharmaceuticals press release.
