CoLucid Pharmaceuticals Announces Achievement of Both Primary and Key Secondary Endpoints in the SAMURAI Phase 3 Pivotal Trial of Lasmiditan in Migraine
100 mg and 200 mg doses of lasmiditan efficacious on headache pain freedom and most bothersome symptom free at the two-hour time point (p < 0.001)
Lasmiditan was well tolerated with no significant difference in cardiovascular adverse events in patients dosed with lasmiditan vs. placebo
SAMURAI conducted under Special Protocol Assessment agreement with FDA
Conference call being held Tuesday, September 6, 2016 at 9:00 a.m. EDT
CAMBRIDGE, Mass., Sept. 06, 2016 -- CoLucid Pharmaceuticals, Inc. (CLCD), a biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, with or without aura, announced today that its Phase 3 pivotal study evaluating lasmiditan, the SAMURAI study, achieved both the primary and key secondary efficacy endpoints with statistical significance (p < 0.001). Lasmiditan was also well tolerated. SAMURAI was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug Administration (“FDA”).
- Published: 06 September 2016
- Written by Editor