Satsuma Pharmaceuticals has initiated the SUMMIT Phase 3 trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine, the company said. A previous Phase 3 trial of STS101 called EMERGE failed to meet its primary endpoints. Topline data from the SUMMIT trial are expected in the second half of 2022.
The SUMMIT trial is expected to enroll approximately 1,400 migraine patients who will get either 5.2 mg of STS101 or placebo for treatment of their next migraine that is at least moderately severe. Primary endpoints are freedom from pain and freedom from “the most bothersome symptom” (photophobia, phonophobia, or nausea) 2 hours post dosing.
Satsuma President and CEO John Kollins said, “We are pleased to have initiated the SUMMIT trial and begun randomizing subjects in accordance with our previously communicated timeline objectives. We believe the likelihood of success for SUMMIT is high given the utilization of the second-generation STS101 nasal delivery device and improved subject training in combination with the trial design and conduct adjustments we’ve made based on our analyses of results from the previous EMERGE Phase 3 trial. We believe SUMMIT will provide the basis for STS101, with subsequent FDA approval, to become the first and only DHE product to have established efficacy on the current standard and FDA-accepted endpoints for acute treatment of migraine in a randomized, placebo-controlled trial.”
Read the Satsuma Pharmaceuticals press release.
