Actionable news
0
All posts from Actionable news
Actionable news in CLCD: CoLucid Pharmaceuticals Inc,

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 (GLOBE NEWSWIRE) -- 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”).

Efficacy

The primary endpoint of SAMURAI was the efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo based on freedom from migraine headache pain two hours after dosing. The key secondary endpoint was the efficacy of lasmiditan based on freedom from the most bothersome associated symptom (MBS) of migraine (nausea, phonophobia or photophobia) two hours after dosing. Data from the study were collected using electronic diaries during the treated attack. Beginning pre-dose, patients indicated their degree of headache pain on a 4-point scale: 0, no pain; 1, mild pain; 2, moderate pain; or 3, severe pain. Patients also...


More