Lasmiditan wins FDA approval for acute migraine

  • FDA

  • Susan London
  • Clinical Essentials
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  • The FDA has approved lasmiditan (Reyvow) tablets for the acute treatment of migraine with or without aura.
  • The drug is not indicated for preventive treatment.

Why this matters

 Key results

  • Efficacy and safety of lasmiditan assessed in pair of phase 3 randomized controlled trials among adults with history of migraine with or without aura (22% taking preventive medication):
    • SAMURAI: tested 2 doses among 1856 patients.
    • SPARTAN: tested 3 doses among 2583 patients.
  • Trial patients allowed to take rescue medication 2 hours after taking study drug, but opioids, barbiturates, triptans, ergots not allowed within 24 hours.
  • In both trials, compared with placebo, lasmiditan at all doses netted significantly higher 2-hour rates of resolution of:
    • Headache pain.
    • Most bothersome migraine symptom (nausea, light sensitivity, sound sensitivity).
  • Most common adverse effects: dizziness, fatigue, paresthesia, sedation.
  • Lasmiditan can impair driving ability; patients should not drive or operate machinery for at least 8 hours after taking a dose.
  • Drug may also cause CNS depression, so it should be used with caution if combined with alcohol, other CNS depressants.
  • For more info, see Prescribing Information and Medication Guide.
  • Ongoing open-label phase 3 GLADIATOR trial is assessing long-term safety.

Expert comment

  • “Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans,” Nick Kozauer, MD, acting deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement. “We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine.”