According to Satsuma Pharmaceuticals, the FDA has approved the company’s NDA for Atzumi dihydroergotamine nasal powder (STS101) for the treatment of migraine in adults. Although the Phase 3 SUMMIT trial of STS101 failed to meet its primary endpoints, Satsuma submitted an NDA for the intranasal DHE in March 2023, and the FDA issued a CRL to that application in January 2024. Satsuma re-submitted the NDA in October 2024, and the agency accepted it for review in November 2024.
Satsuma President and CEO Ryoichi Nagata commented, “The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL’s novel intranasal drug delivery platform technology. We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems.”
Read the Satsuma Pharmaceuticals press release
