Another promising drug for migraines is moving closer to approval.
Eli Lilly reported lasmiditan, an investigational oral first-in-class molecule for the acute treatment of migraines, achieved dosing goals in a second Phase III study called SPARTAN.
SPARTAN is a randomized, double, placebo-controlled trial assessing the safety and efficacy of three different doses of lasmiditan on patients who experienced at least moderate migraine disability. Most participants had an average of more than five migraine attacks per month at baseline.
Investigators tested the impact of 50 mg, 100 mg, or 200 mg against placebo on these patients.
The primary endpoint was reached when the percentage of patients who were migraine pain-free was statistically significantly greater compared to placebo in all dosing groups. It broke down to 28.6 percent for the 50 mg cohort, 31.4 percent for the 100 mg group and 38.8 percent for 200 mg compared 2.13 percent for placebo.
Furthermore, key secondary endpoints when a statistically significant greater percentage of patients were free of their most bothersome symptoms like nausea and sensitivity to sound versus placebo were met two hours following the first dose, according to the announcement.
“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 Lilly Bio-Medicines president Christi Shaw, in a statement. “We are thrilled with these topline lasmiditan results, which add to more than 25 years of Lilly’s research and development of migraine therapies.”
Common adverse events that were reported included dizziness, paresthesia, and somnolence.
More detailed data from this study as well another investigation labeled SAMURAI will be presented at upcoming scientific meetings while the SPARTAN results will be submitted to peer-reviewed journals within the next year.
Also, Eli Lilly plans on submitting a New Drug Application to the U.S. Food and Drug Administration in the second half of 2018.
Filed Under: Drug Discovery