CoLucid Pharmaceuticals announced positive data from the pivotal SAMURAI study, evaluating lasmiditan oral tablets for the acute treatment of migraine in adults, with or without aura.
SAMURAI was a randomized, double-blind, placebo-controlled parallel-group Phase 3 trial which evaluated the efficacy and safety of two doses of lasmiditan in patients with migraines. Patients either received lasmiditan 100mg, 200mg or placebo. The primary endpoint was the efficacy of lasmiditan vs. placebo based on freedom from migraine headache pain 2 hours after dosing. Key secondary endpoint was the efficacy of lasmiditan based on freedom from the most bothersome associated symptom (MBS) of migraine (nausea, phonophobia or photophobia) 2 hours after dosing. Data was collected with the use of electronic diaries during the treated attack.
Results showed that the study achieved statistical significance in both the primary and key secondary efficacy endpoints for the lasmiditan-treated patients (P<0.001). The percentage of patients who were migraine headache pain free at 2 hours was 28.2% for the lasmiditan 100mg arm, 32.2% for the lasmiditan 200mg arm, vs. 15.3% for the placebo arm. The percentage of patients who were MBS free at 2 hours was 40.9%, 40.7%, vs. 29.5%, respectively.
Lasmiditan was found to be generally well-tolerated, with 91% of adverse events (AEs) presenting to be mild and moderate in nature. There was no significant difference in cardiovascular AEs between lasmiditan and placebo, and the majority of treatment emergent adverse events (TEAE) were nervous system related. Detailed study findings will be presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC 2016) on September 17, 2016.
CoLucid is currently enrolling patients in a second Phase 3 trial, the SPARTAN study, and in a long-term, open-label Phase 3 trial, the GLADIATOR study, to evaluate the safety and efficacy of lasmiditan for migraines. Successful results from these trials will support its submission for a New Drug Application (NDA).
Lasmiditan is a selective 5-HT1F receptor agonist designed to treat acute migraine headaches without the vasoconstrictor activity associated with previous generations of migraine therapies.
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