Phase III SAMURAI and SPARTAN studies of lasmiditan show efficacy in migraine

Eli Lilly announced new data and post-hoc analyses for lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, including pooled analyses from the Phase III SAMURAI and SPARTAN studies. The first analysis reviewed data on the early onset of effect of lasmiditan for several key outcomes. The second analysis shared data on the effect of lasmiditan in patients who took a triptan within the three months prior to study participation.

In addition to these new analyses, Lilly presented interim results from the Phase III, one-year, open-label extension study of lasmiditan (GLADIATOR) that showed results on measures of safety and efficacy were generally consistent with observations from the SAMURAI and SPARTAN studies. A pooled analysis of these Phase III studies was conducted to determine the onset of improvement in migraine symptoms after taking lasmiditan (50 mg, 100 mg or 200 mg) versus placebo. Rates of pain relief, and freedom from most bothersome symptom (MBS; patient selected from nausea, photophobia which is sensitivity to light, or phonophobia, which is sensitivity to sound) were both higher and statistically significant starting as early as 30 minutes post-dose in the lasmiditan 100 mg and 200 mg treated groups (p<0.05) when compared with placebo. The 200 mg lasmiditan treated group also achieved higher and statistically significant rates of freedom from photophobia and phonophobia than placebo starting as early as 30 minutes post-dose (p<0.05). The primary endpoint of freedom from pain was statistically significant for both the 100 mg and 200 mg doses starting at 60 minutes (p<0.05 and p<0.001, respectively).

The results based on prior experience with Triptan Therapy from the Phase III SAMURAI and SPARTAN studies showed that patients taking lasmiditan experienced higher rates of freedom from pain, freedom from MBS and pain relief versus placebo, regardless of prior experience with triptans. Finally GLADIATOR interim results show that the most frequent treatment-emergent adverse events (TEAEs) (more than 2%) were dizziness (18.6%), somnolence (sleepiness or drowsiness; 8.5%), paresthesia (tingling or numb sensation on the skin; 6.8%), fatigue (5.5%), nausea (4.7%) and asthenia (physical weakness or lack of energy; 2.0%). The incidence and types of TEAEs were similar to those in the SAMURAI and SPARTAN studies. The data are being presented at the Annual Meeting of the American Academy of Neurology (AAN).