Following the failure of the Phase 3 SUMMIT trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine to meet the study’s primary endpoints, Satsuma Pharmaceuticals says that the company will not invest in commercialization of the product. In September 2020, the company announced that the Phase 3 EMERGE trial of STS101 failed to meet its primary endpoints. However, Satsuma said that it believes that results from two other trials — a Phase 1 PK study and the Phase 3 ASCEND trial — will be enough to support an NDA submission and approval.
According to Satsuma, the SUMMIT trial, which was initiated in July 2021, failed to demonstrate that STS101 was statistically superior to placebo for either freedom from pain or freedom from most bothersome symptom at 2 hours post-dose, the company said; however, the trial did demonstrate significant improvements in both at 3 hours post-dose and thereafter as well as statistical superiority on several secondary clinically-relevant endpoints.
Satsuma President and CEO John Kollins said, “We are surprised and disappointed that STS101 did not demonstrate statistically significant superiority over placebo at two-hours post treatment on the SUMMIT study co-primary endpoints. However, based on our interactions to date with the FDA, we believe the results from the STS101 Phase 1 pharmacokinetic and ASCEND Phase 3 open-label, long-term safety trials will support the STS101 NDA filing and marketing approval. A large proportion of people with migraine do not achieve sufficient and sustained relief with current treatments, and we believe that in total, the data from the STS101 clinical program, in which more than 1,600 subjects treated more than 8,500 migraine attacks with more than 10,000 doses of STS101, demonstrate that STS101 has a differentiated profile and may address the unmet needs of many patients.”
Read the Satsuma Pharmaceuticals press release.
