Eli Lilly’s investigational migraine treatment has met its primary endpoint in a second Phase 3 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.
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 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.
“Lasmiditan represents the first significant innovation in the acute treatment of migraine in more than 20 years, and could provide a much-needed new treatment option for the 36 million Americans living with migraine,” said Christi Shaw, president of Lilly Bio-Medicines.
“We are thrilled with these topline lasmiditan results, which add to more than 25 years of Lilly’s research and development of migraine therapies.”
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 3 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 annual meeting in June.
Lilly plans to submit a New Drug Application for lasmiditan to the US Food and Drug Administration in the second half of 2018.