WASHINGTON -- The FDA on Friday (Reyvow) for treating acute migraines, with or without aura, in adult patients.
The drug "is a new option for the acute treatment of migraine, a painful condition that affects one in seven 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, a serotonin agonist which targets the 5-HT1F receptor, is first in its class to win approval and can be used for acute treatment only, not migraine prevention. Its effectiveness in acute migraine was demonstrated in two randomized, double-blind, placebo-controlled trials of 3,177 adult patients, the agency reported.
In both studies, the percentages of patients whose pain resolved and who had their most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolve 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.
"The presumed mechanism of action of lasmiditan is to terminate migraine in the brain stem and prevent processing of the migraine centrally," Stewart Tepper, MD, of the Geisel School of Medicine at Dartmouth College in Hanover, New Hampshire, said in an interview with 鶹ý last year. This may be why lasmiditan appears to have central nervous system (CNS) adverse effects, including dizziness and drowsiness.
The most common side effects reported in the trials were dizziness, fatigue, paresthesia, and sedation. Driving impairment is a risk with lasmiditan and patients should be advised to not drive or operate machinery for at least 8 hours after taking the drug, even if they feel well enough to do so, the FDA warned. Patients who cannot follow this advice are advised not to take lasmiditan. The drug should be used with caution if taken with alcohol or other CNS depressants, the agency said.
The recommended for lasmiditan currently is under DEA review and is expected within 90 days; after that occurs, lasmiditan will be in retail pharmacies, drugmaker Eli Lilly said in a . Once available, lasmiditan can be prescribed to patients in oral doses of 50 mg, 100 mg, and 200 mg as needed, they added.