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# Lilly Plans 2018 NDA for Migraine Drug After Trial Results
- URL: https://www.fdaweb.com/lilly-plans-2018-nda-for-migraine-drug-after-trial-results/
- Published: 2017-08-04T12:00:00.000Z
- Updated: 2026-09-14T22:39:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139306

Eli Lilly says its investigational migraine drug lasmiditan met its primary endpoint in SPARTAN, a second Phase 3 study of the therapy. A greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo after two hours, it says. The results were statistically significant across all three studied doses (50 mg, 100 mg and 200 mg). The therapy also met a key secondary endpoint for SPARTAN across all three studied doses, “with a statistically significantly greater percentage of patients free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose,” Lilly adds. “In this study, patients chose their MBS from nausea, sensitivity to sound or sensitivity to light.”

  
The findings are consistent with SAMURAI, the first pivotal Phase 3 study evaluating lasmiditan for the acute treatment of migraine. Lilly plans to submit an NDA for lasmiditan in the second half of 2018.