FDA Approves Acute Migraine Treatment for Adults

On October 11, 2019, the FDA approved lasmiditan (REYVOW™) for the acute treatment of migraine, with or without aura, in adults. This oral treatment is the first FDA-approved medicine in a new class of acute migraine treatment (serotonin (5-HT)1F receptor agonists). 

Two separate Phase III, placebo-controlled studies evaluated the safety and efficacy of lasmiditan. Both studies found that patients who were administered lasmiditan reported higher levels of pain freedom. They also reported freedom from most bothersome patient-selected symptoms after 2 hours. Lasmiditan’s adverse effects were most frequently found to include dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness. Other side effects that were also reported included significant driving impairment and central nervous system depression. 

In an FDA-required assessment of medications with central nervous system activity, therapeutic doses of lasmiditan were associated with less drug liking, compared with alprazolam. However, lasmiditan was associated with more drug liking compared with placebo. This demonstrates a lower potential for abuse compared with alprazolam. The recommended controlled substance classification for lasmiditan is currently under review by the Drug Enforcement Administration. The DEA’s assessment is expected within 90 days of FDA’s approval. After this time, REYVOW™ will be available to patients in retail pharmacies in oral doses of 50 mg, 100 mg, and 200 mg as needed.

For more information about the lasmiditan that can be used to inform treatment decisions, click here.