Lasmiditan Effective in Phase 3 Trial for Acute Migraine

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Eli Lily and Company is planning to submit a New Drug Application for lasmiditan to the FDA in the second half of 2018.
Eli Lily and Company is planning to submit a New Drug Application for lasmiditan to the FDA in the second half of 2018.

Eli Lilly announced positive results from a Phase 3 trial (SPARTAN) of their first-in-class drug lasmiditan for the acute treatment of migraine.1

Lasmiditan selectively targets 5-HT1F receptors expressed in the trigeminal pathway, and has been designed for the acute treatment of migraine without the vasoconstrictor activity associated with some migraine therapies.

SPARTAN is a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of three doses of lasmiditan administered orally (50mg, 100mg or 200mg) compared with placebo for the acute treatment of migraine. Results showed that a statistically significant number of participants who received lasmiditan (in all doses) were pain-free 2-hours post dosage compared to those who received placebo (the primary endpoint).

Specifically, the percentage of patients who were migraine pain-free in the 50 mg, 100 mg, and 200 mg lasmiditan groups was 28.6% (=.003), 34.4% (<.001), and 38.8% (<.001), respectively. The corresponding percentage for the placebo group was 21.3%.

The lasmiditan group also demonstrated statistically greater results in being free of patient-selected most bothersome symptom (MBS), the trail's secondary endpoint. These included nausea, sensitivity to sound and/or light, among others. A total of 40.8% of the 50 mg group (=.009), 44.2% of the 100 mg group (P <.001), and 48.7% of the 200 mg group (<.001) were free from their MBS compared to 33.5% in the placebo group. The SPARTAN results are in line with results from the first Phase 3 lasmiditan study, SAMURAI.

“Lasmiditan represents the first significant innovation in the acute treatment of migraine in more than 20 years, and could provide a much-needed new treatment option for the 36 million Americans living with migraine,” said Christi Shaw, president of Lilly Bio-Medicines.

The company is planning to submit a New Drug Application for lasmiditan to the Food and Drug Administration in the second half of 2018.

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Reference

  1. Lilly announces positive results for second phase 3 study of lasmiditan for the acute treatment of migraine [press release]. Indianapolis: Eli Lilly and Company; August 4, 2017.
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