The Food and Drug Administration (FDA) has approved Reyvow (lasmiditan; Lilly) for the acute treatment of migraine with or without aura in adults.
The approval of lasmiditan, a serotonin (5-HT) 1F receptor agonist, was based on data from two phase 3 trials, SAMURAI and SPARTAN. Results across both studies showed that a significantly greater percentage of patients treated with lasmiditan were migraine pain-free 2 hours following the first dose vs those who received placebo. In addition, compared with placebo, more patients in the lasmiditan group were found to be free of their most bothersome symptom at 2 hours following the first dose.
With regard to safety, the most common treatment-emergent adverse reactions included dizziness, fatigue, paresthesia, and sedation. As the drug causes CNS depression, patients are advised not to drive or operate machinery for at least 8 hours after taking Reyvow; prescribers should be aware that patients may not be able to assess their own driving competence and the degree of impairment caused by the drug. Reyvow is not indicated for the preventive treatment of migraine.
Commenting on the approval, Jan Brandes, MD, MS, FAAN, assistant clinical professor, Department of Neurology, Vanderbilt University said, “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.”
Reyvow will be supplied in 50mg and 100mg tablet strengths. The drug is currently being reviewed by the Drug Enforcement Administration (DEA) and a controlled substance classification is expected within 90 days. To better understand the potential for abuse, the Company conducted a human abuse potential study which showed statistically significantly higher “drug-liking” scores with Reyvow vs placebo, but lower scores when compared with alprazolam.
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