On Friday, the U.S. Food and Drug Administration approved lasmiditan (Reyvow; Lilly) for acute treatment of migraine with or without aura in adults. Lasmiditan is the first of a new class of migraine medications—serotonin (5-HT)1F receptor agonists—that has seen a flurry of recent trials in the last two years. 

“[Lasmiditan] is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans,” said Nick Kozauer, M.D., acting deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Human brain illustration. Source: Getty

The FDA cited the results from two phase 3 randomized, double-blind, placebo-controlled trials, SAMURAI and SPARTAN. The trials enrolled a total of 3,177 patients with a history of migraine with or without aura. In both, the “percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved two hours after treatment were significantly greater among patients receiving Reyvow at all doses compared to those receiving placebo,” the FDA noted. 

Lasmiditan is a central nervous system depressant and patients should not drive or operate heavy machinery within eight hours of taking the drug, even if they feel well enough to do so. Patients should also exercise caution when taking the drug with alcohol or other CNS depressants. 

Because it acts on the central nervous system, lasmiditan required an assessment of human abuse potential as well as the usual safety and efficacy studies. Those studies determined that therapeutic doses of lasmiditan were associated with less drug liking compared to alprazolam, but more than placebo. The controlled substance classification for lasmiditan is now under consideration by the Drug Enforcement Administration. An announcement of the classification is expected by the end of the year, after which the drug will be available to patients through retail pharmacies, according to the manufacturer.