FDA Approves First-in-class Oral Agent for Adults with Migraine

The FDA on Friday, October 11, 2019, approved lasmiditan (Reyvow, Eli Lilly)-a first-in-class oral agent for treatment of acute migraine, with or without aura, in adults. 

The drug "is a new option for the acute treatment of migraine, a painful condition that affects 1 in 7 Americans," Nick Kozauer, MD, acting deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."

Lasmiditan is a serotonin agonist which targets the 5-HT1F receptor and is approved for acute migraine relief only, not as migraine preventive. It is the first 5-HT1F receptor agonist to receive approval. According to the FDA, the effectiveness of lasmiditan in the treatment of acute migraine was demonstrated in in 2 phase 3, randomized, double-blind, placebo-controlled trials (SAMURAI and SPARTAN) of 3,177 adult patients.

Freedom from pain and worst symptom

In both studies, the percentages of patients who had freedom from pain and from their most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) at 2 hours after treatment were significantly greater in patients taking lasmiditan than placebo. Although patients were allowed to take a rescue medication 2 hours after lasmiditan was given, opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of taking the drug. In total, 22% percent of patients in the trials also used preventive migraine medication.

Adverse events were generally mild to moderate and the most frequent included dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness. It is presumed that the mechanism of action of lasmiditan is to abort migraine at the level of the brainstem which may account for the observed central nervous system (CNS) effects.

FDA cautions

FDA warned in its release that patients should be advised not to drive or operate machinery for at least 8 hours after taking lasmiditan, even if they feel well enough to do so. Anyone not able to comply with this advice should not take lasmitidan. Caution is advised if the drug is taken with alcohol or other CNS depressants.

Drug-maker Eli Lilly said in a press release that the company conducted a human abuse potential assessment of lasmitidan-required by FDA for all medications with CNS activity. Therapeutic doses of lasmitidan in that assessment were associated with less drug liking when compared to alprazolam, but more than placebo. The recommended controlled substance classification for lasmitidan is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of Friday’s FDA approval, after which the drug will be available to patients in retail pharmacies.

Once available, lasmiditan can be prescribed to patients in oral doses of 50 mg, 100 mg, and 200 mg as needed, they added.