Satsuma Pharmaceuticals announced that it has initiated the Phase 3 EMERGE trial of STS101 dihydroergotamine (DHE) nasal powder for the acute treatment of migraine. In April 2019, Satsuma announced that it had raised $62 million to fund Phase 3 development of STS101.
The study, which is expected to enroll approximately 1,140 migraine patients, will compare two doses of STS101 to placebo. Primary endpoints of the study will be freedom from pain, light and noise sensitivity, and nausea two hours post-dosing. The company said that it anticipates reporting top-line data in the second half of 2020.
Satsuma President and CEO John Kollins said, “We are pleased to have recently dosed the first patient in our Phase 3 EMERGE efficacy trial, which we believe is the largest-ever clinical trial undertaken with any DHE product. This milestone brings us a step closer to achieving our goal of making STS101, a compact, simple-to-use, self-administered, and non-injectable DHE dosage form, available as a differentiated treatment option for people with migraine.”
Read the Satsuma Pharmaceuticals press release.
