Satsuma Pharmaceuticals said that the Phase 3 EMERGE trial of its STS101 dihydroergotamine nasal powder for the treatment of migraine failed to demonstrate statistically significant improvement in either pain relief or the patient’s most bothersome symptom compared to placebo for either of the doses tested at two hours post dosing. The company had announced the initiation of the EMERGE trial in August 2019.
According to Satsuma, both dosage strengths did demonstrate significant improvement compared to placebo for both measures at three hours after administration and later. Both dosages were also well tolerated, with no serious adverse events.
Any decision about the future of STS101 will be made after further evaluation of the trial data, the company said. Satsuma was spun out from Shin Nippon Biomedical Laboratories (SNBL) in 2017 specifically for development of the intranasal DHE product.
Satsuma President and CEO John Kollins commented, “We are surprised and disappointed that STS101 did not achieve statistical significance on the co-primary endpoints in our EMERGE trial. On behalf of everyone at Satsuma, I’d like to thank the many people with migraine who participated in EMERGE as well as the staff at the trial sites for their dedication and diligence in completing the trial, despite the challenges posed by the ongoing COVID-19 pandemic.”
Read the Satsuma Pharmaceuticals press release.
