Safety Findings from the Phase 3 Studies (SAMURAI, SPARTAN) of Lasmiditan for Acute Treatment of Migraine (P1.10-009)

Objective: To assess the safety profile of lasmiditan based on findings from the Phase 3 studies, SPARTAN and SAMURAI. Background: Lasmiditan is a 5-HT 1F receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine. SPARTAN and SAMURAI were double-blind studies of patients with migraine, randomized to oral lasmiditan 50mg (SPARTAN only), 100mg, 200mg, or placebo to be taken within 4 hours of onset of a migraine attack. If needed for rescue/recurrence, a second randomized dose could be taken. Design/Methods: Safety data from SPARTAN and SAMURAI were integrated. Treatment-emergent adverse events (TEAEs) (occurred within 48 hours of first dose, regardless of whether second dose taken) were considered in the analyses. Results: The safety population comprised 1262 participants assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50mg, 100mg, and 200mg, respectively. There were no deaths; serious adverse events were reported for 7 participants (placebo, n=2 [0.2%]; lasmiditan 50mg, n=1 [0.2%]; lasmiditan 100mg, n=1 [0.2%]; lasmiditan 200mg, n=3 [0.2%]). Participants reporting ≥1 TEAE were - Placebo, n=174 (13.5%); lasmiditan 50mg, n=166 (25.4%); lasmiditan 100mg, n=458 (36.2%); and lasmiditan 200mg, n=510 (40.3%). TEAEs were generally mild or moderate in severity. TEAEs in ≥2% of any lasmiditan dose group and more frequent with lasmiditan than placebo (p Conclusions: As a centrally-penetrant drug, lasmiditan use was associated with neurologic TEAEs most mild or moderate, of quick onset and self-limiting. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174) Disclosure: Dr. Krege has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Krege has received compensation for serving on the Board of Directors of Eli Lilly and Company. Dr. Krege holds stock and/or stock options in Eli Lilly and Company. Dr. Liffick has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Doty has received personal compensation for consulting and serving on a scientific advisory board with Eli Lilly and Company, and has received personal compensation for speaking with the Allergan Botox Speakers Bureau, Amgen Speakers Bureau, and Teva Speakers Bureau. Dr. Doty holds stock and/or stock options in Eli Lilly and Company. Dr. Dowsett has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Wang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Buchanan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Co.