Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN

We assessed the safety profile of lasmiditan, a selective 5-HT1F receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50？mg (SPARTAN only), 100？mg, 200？mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses. The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50？mg, 100？mg, and 200？mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n？=？2 [0.2%]; lasmiditan 50？mg, n？=？1 [0.2%]; lasmiditan 100？mg, n？=？1 [0.2%]; lasmiditan 200？mg, n？=？3 [0.2%]). Patients reporting？≥？1 treatment-emergent adverse events were: Placebo, n？=？174 (13.5%); lasmiditan 50？mg, n？=？166 (25.4%); lasmiditan 100？mg, n？=？458 (36.2%); and lasmiditan 200？mg, n？=？510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events. As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting. SAMURAI (NCT02439320) and SPARTAN (NCT02605174)