According to Satsuma Pharmaceuticals and its parent company Shin Nippon Biomedical Laboratories, the FDA has accepted the company’s resubmitted NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine and has set a PDUFA date of April 30, 2025. Satsuma submitted the now-accepted NDA in October 2024.
In March 2023, Satsuma submitted the original NDA for STS101 despite the failure of the Phase 3 SUMMIT trial of STS101 to meet its primary endpoints, and the FDA accepted that application and set a PDUFA date in January 2024. Then in January 2024, the agency issued a CRL to the application.
Satsuma’s website describes the STS101 nasal powder as a formulation of engineered DHE particles and a mucoadhesive carrier. The formulation is delivered via a proprietary device.
Read the Satsuma Pharmaceuticals press release.
