Lasmiditan, met its primary endpoint in SPARTAN, a second Phase III study for the acute treatment of migraine.- Eli Lilly

Eli Lilly and Company announced that lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, met its primary endpoint in SPARTAN, a second Phase III study. At two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo. These results were statistically significant across all three studied doses (50 mg, 100 mg and 200 mg). Lasmiditan also met the key secondary endpoint for SPARTAN across all three studied doses, with a statistically significantly greater percentage of patients free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose. In this study, patients chose their MBS from nausea, sensitivity to sound or sensitivity to light.

The most commonly-reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea and lethargy. These findings are consistent with SAMURAI, the first pivotal Phase III study evaluating the safety and efficacy of lasmiditan for the acute treatment of migraine. In this study, lasmiditan met both the primary and key secondary endpoints with statistical significance. Results from SAMURAI were presented at the American Headache Society (AHS) annual meeting in June. Lilly plans to submit a New Drug Application for lasmiditan to the FDA in the second half of 2018.