Satsuma Pharmaceuticals said that the FDA has accepted the company’s 505(b)(2) NDA for STS101 nasal powder dihydroergotamine for the treatment of migraine, and Satsuma expects the agency to set a PDUFA goal date in January 2024. Satsuma recently agreed to be reacquired by Shin Nippon Biomedical Laboratories (SNBL).
According to Satsuma, data from the Phase 3 SUMMIT trial of STS101, which failed to meet its primary endpoints, were included in the submission along with data from the Phase 3 ASCEND trial, which used a second generation delivery device, as well as data from a Phase 1 PK and safety study. The Phase 3 EMERGE trial of STS101 also failed to meet its primary endpoint.
Satsuma President and CEO John Kollins commented, “We are proud to announce the FDA acceptance for review of our STS101 NDA, as it represents an important milestone for our company and an important step toward achieving our goal of making STS101 available as an easy-to-use, effective, and safe and well-tolerated DHE treatment that can address the significant unmet clinical needs of many people with migraine.”
Read the Satsuma Pharmaceuticals press release.
