Reyvow (lasmiditan) approved for acute migraine

  • Food and Drug Administration

  • Kelli Whitlock Burton
  • Clinical Essentials
L'accesso ai contenuti di questo sito è riservato agli operatori del settore sanitario italiano L'accesso ai contenuti di questo sito è riservato agli operatori del settore sanitario italiano

Takeaway

  • Reyvow (lasmiditan) has received FDA approval for the acute treatment of migraine with or without aura.

Why this matters

  • About 12% of US adults have a history of migraine.

Key points

  • Recommended daily dosage 50 mg, 100 mg, or 200 mg taken orally, as needed.
  • May cause significant driving impairment, central nervous system depression, serotonin syndrome, and medication overuse headache.
  • Approval based on 2 randomized, double-blind, placebo-controlled trials of 3177 patients with adult migraine:
    • Study 1: Pain relief at 2 hours in 28.3% with 100 mg lasmiditan and 31.8% with 200 mg vs 15.3% with placebo (P<.001 relief of most bothersome symptom at hours was reported in with mg lasmiditan and vs placebo>
    • Study 2: Pain relief at 2 hours was 28.3% with 50 mg lasmiditan, 31.4% with 100 mg, and 38.8% with 200 mg vs 21.0% with placebo (P<.001 relief of most bothersome symptom at hours was reported in with mg lasmiditan and vs placebo>
  • Not indicated for the prevention of migraine.
  • Most frequent adverse effects are dizziness, fatigue, paresthesia, and sedation.

For Prescribing Information, click here.