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Lilly’s migraine med lasmiditan successful in another late-stage study

September 11, 2020

Eli Lilly (NYSE:LLY) announces positive results from a 1,471-subject Phase 3 clinical trial, CENTURION, evaluating 100 mg and 200 mg doses of Reyvow (lasmiditan) for the acute treatment of migraine in adults, with or without aura, across four attacks. The data are being presented virtually at PAINWeek.

Reyvow showed its superiority over placebo on all gated endpoints, including proportions of study participants who after treating their first migraine attack reported pain freedom at 1 hour (200 mg dose), pain relief at 1 hour and 2 hours (both doses), sustained pain freedom at 24 hours (both doses) and 48 hours (200 mg dose), and no disability at 2 hours (both doses).

The proportion of patients achieving pain freedom at hour 2 in the 200 mg arm was 29.3% versus 8.4% in the control arm (p<0.001). The proportion achieving the same endpoint in the 100 mg arm was 25.8% (p<0.001).

The proportions of patients in the 200 mg and 100 mg arms achieving sustained pain freedom at hour 24 were 17.3% and 13.6%, respectively, compared to 4.3% in the placebo arm (both p values were less than 0.001).

Two earlier Phase 3s, SAMURAI and SPARTAN, were also successful. The FDA approved the 5-HT1F receptor agonist in October 2019.

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