Lilly's Lasmiditan Meets Primary, Secondary Endpoints in Phase 3 Trials for Migraine

Eli Lilly is sharing positive results from a second phase 3 trial for lasmiditan, an investigational oral treatment for acute migraine.

Lasmiditan met the primary and secondary endpoints of the SPARTAN trial, a phase 3, double-blind, placebo-controlled global trial evaluating the drug’s safety and efficacy in 50, 100 and 200 mg doses.

The primary endpoint measured the percentage of patients who were migraine free 2 hours after taking lasmiditan compared to placebo, and was statistically significant, according to a Lilly statement. 28.6% (p=0.003) of patients who took the 50mg dose were migraine-free after 2 hours, and 31.4% (p<0.001) and 38.8% (p<0.001) were migraine free after taking 100mg and 200mg doses, respectively, compared with 21.3% of patients in the placebo group.

Moreover, statistically significantly more patients who were treated with lasmiditan were free of their migraine-associated most-bothersome symptom (MBS) at 2 hours following first dose compared to placebo. MBS included nausea and sensitivity to sound or light. The percentage of patients who experienced less migraine pain and migraine disability was statistically significant, according to the statement.

An additional open-label phase 3 study — GLADIATOR – is currently underway to evaluate the long-term safety of lasmiditan for the acute treatment of migraine.

Lilly plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in the second half of 2018. The company will present more data from its studies at scientific meetings and submit the its findings to peer-reviewed journals within the next year.

“Lasmiditan has been designed to target receptors associated with migraine without the vasoconstrictor activity associated with some migraine therapies,” said Robert Conley, MD, distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics. “We hope these results are a significant step toward the development of new acute migraine treatments for the millions of patients in need, including those who may be poorly served by existing therapies or those with cardiovascular disease or risk factors.”