According to Satsuma Pharmaceuticals parent company Shin Nippon Biomedical Laboratories, the FDA has issued a complete response letter to Satsuma’s NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine. SNBL said that the CRL cited CMC issues only and did not request any additional clinical data or new clinical trials. The company added that it intends to meet with the FDA regarding a resubmission and will provide an update on timing after that consultation.
Satsuma submitted the NDA in March 2023 despite the failure of the Phase 3 SUMMIT trial of STS101 to meet its primary endpoints, and the agency accepted the application for review in May 2023. In addition to the SUMMIT trial, the Phase 3 EMERGE trial also failed to meet its primary endpoint.
Satsuma President and CEO Ryoichi Nagata commented, “We remain committed to working expeditiously with the FDA to complete the review for STS101 as soon as possible.”
Read the SNBL press release.
