FDA Approves Lasmiditan for Acute Treatment of Migraine Attacks

  • Headache
  • Lasmiditan
  • Migraine

The Food and Drug Administration (FDA) has approved lasmiditan (Reyvow; Lilly, Indianapolis, IN) tablets for the acute treatment of migraine with or without aura in adults. Although several new and migraine-specific treatments for the prevention of chronic or episodic migraine that reduce headache frequency have recently been approved, breakthrough headache still occurs for most people with migraine. Such breakthrough headaches make the need for effective acute treatments specific to migraine a high unmet need. 

This week, individuals who experience the pain and disability of migraine attacks have a new option for treatment. Lasmiditan is a first-in-class novel serotonin 5-HT1F receptor agonist.  In clinical trials dizziness, fatigue, paresthesia, and sedation side effects occurred and in human abuse potential studies, therapeutic doses were associated with less drug liking compared to the positive control alprazolam, but more than the negative placebo control. A recommended controlled substance classification is underway at the Drug Enforcement Administration (DEA), and a scheduling decision is expected within 3 months.

Approval of lasmiditan is based on efficacy for acute treatment of migraine seen in the SAMURAI (NCT02439320) and SPARTAN (NCT02605174) clinical trials. In these 2 trials, 3,177 adults with a history of migraine with or without aura, 22% of whom were also using with a preventive medication at the time, treated a migraine attack with lasmitidan. With doses of 100 mg or 200 mg of lasmiditan vs placebo, significantly higher numbers of participants had freedom from pain and most bothersome symptoms as early as 60 minutes after treatment (P < .01). Patients reporting “no disability” due to migraine was also significantly greater at 60 minutes, for individuals who took a 200-mg dose of lasmiditan vs placebo (P =.001). 

"As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating," said Jan Brandes, MD, MS, FAAN, assistant clinical professor, Department of Neurology, Vanderbilt University. "With new science comes new hope. Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like REYVOW is an important development for physicians and the patients we treat.”

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