CoLucid Pharmaceuticals, Inc., Announces Agreement from the FDA on a Special Protocol Assessment (SPA) for the Phase 3 Trial of Lasmiditan in Migraine Including Patients with Risk Factors for Cardiovascular Disease
Durham, NC, MAY 6, 2014/PRNewswire/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, has reached agreement with the U.S. Food and Drug Administration (FDA) for the planned SAMURAI study. The objective of this trial is to evaluate the safety and efficacy of two doses of Lasmiditan in comparison to placebo for the treatment of acute migraine. Patients with risk factors for cardiovascular disease will be included in the study.
The SPA agreement includes two novel endpoints for the approval of acute migraine therapies—a primary endpoint of the proportion of patients who are free of headache pain at 2 hours and a key secondary endpoint of the proportion of patients who no longer suffer from their most bothersome associated symptom of migraine (nausea, photophobia, phonophobia) at 2 hours.