Eli Lilly's migraine drug Lasmiditan has met its primary endpoint in a second phase 3 trial.
According to Lilly, the primary endpoint of the phase 3 SPARTAN trial was comparison of the percentage of patients in the lasmiditan 200mg and placebo groups who were migraine pain-free at two hours after the first dose.
Lasmiditan, which is an investigational, oral, first-in-class molecule was shown to have treated migraine pain in a high percentage of patients after two hours of the first dose of treatment compared to placebo.
Lilly says that the results from the trial were significant statistically for all the three studied doses of 50mg, 100mg and 200mg.
The migraine drug also met a major secondary endpoint in the SPARTAN trial for all the three dosage strengths. In comparison to placebo, lasmiditan yielded a statistically significantly higher percentage of patients who were found to be free of their most bothersome symptom (MBS) at two hours after the first dose.
In other secondary endpoints like migraine pain relief and migraine disability as well Lasmiditan had shown statistically significant improvements when compared to placebo.
Lilly Bio-Medicines president Christi Shaw said: "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.
"We are thrilled with these topline lasmiditan results, which add to more than 25 years of Lilly's research and development of migraine therapies."
As per Lilly, the participating patients had selected among nausea, sensitivity to sound or sensitivity to light as their MBS.
The pharma company says that the results from the SPARTAN trial are in line with the other phase 3 study named SAMURAI which studied lasmiditan’s safety and efficacy for the acute treatment of migraine.
Following positive results from both the phase 3 trials, Lilly intends to submit a New Drug Application for the migraine drug to the US Food and Drug Administration (FDA) in the second half of next year.
Image: Eli Lilly and Company's global headquarters, in Indianapolis, Indiana, US. Photo: courtesy of Guanaco152003/Wikipedia.org.