The initial development program for lasmiditan will address the major unmet need of migraine patients with risk factors for cardiovascular disease and those with stable cardiovascular disease.
Our clinical program is designed to support a request for a differentiated product label for lasmiditan.
- Lasmiditan is not a vasoconstrictor and has a neural mechanism of action
- All triptan labels include warnings, precautions and contraindications against use in patients with cardiovascular risk factors or disease.
- CoLucid intends to develop lasmiditan for the acute treatment of migraine with or without aura without such warnings, precautions and contraindications
CoLucid has completed SAMURAI, the first of two pivotal Phase 3 clinical trials of lasmiditan oral tablets. (see press release).
SAMURAI evaluated the safety and efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia, or photophobia), which is the key secondary endpoint.
SAMURAI was a randomized, double-blind, placebo-controlled parallel group study. 2,231 patients were randomized at approximately 80 U.S. sites. 82% of patients randomized had multiple cardiovascular risk factors (CVRF) or cardiovascular conditions.
The study achieved both the primary and key secondary endpoints. 100 mg and 200 mg doses of lasmiditan were efficacious on headache pain freedom and most bothersome symptom free at the two-hour time point (p<0.001).
Lasmiditan was well tolerated, with the majority of treatment emergent adverse events (TEAE) being nervous system related, and 91% of TEAE in lasmiditan treated patients being described as mild or moderate in nature. Importantly, there was not a reported increase in cardiovascular adverse events in patients who dosed with lasmiditan versus placebo. There were no serious adverse events in SAMURAI that were considered to be related to treatment.
CoLucid is currently enrolling patients in a second pivotal Phase 3 clinical trial of lasmiditan oral tablets, SPARTAN.
The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint. SPARTAN is a randomized, double-blind, placebo-controlled parallel group study.
The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 140 sites in the U.S., United Kingdom and Germany.
CoLucid expects migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”). SPARTAN has been granted a SPA agreement with the FDA.
Top-line results from SPARTAN are expected in mid-2017.
CoLucid is also currently enrolling patients in GLADIATOR, a Phase 3 long-term, open-label trial of lasmiditan.
GLADIATOR’s objective is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability.
Migraine patients who complete CoLucid’s ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company’s second Phase 3 pivotal trial, SPARTAN, will be eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year.
Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support a New Drug Application (“NDA”) for lasmiditan.
At the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan in the entire clinical program.