FDA Approves Lasmiditan for Adult Migraine Attacks

The US Food and Drug Administration (FDA) has approved lasmiditan tablets (Reyvow) for the acute treatment of migraine in adult patients, with or without aura.

The approval, granted to Eli Lilly and Company, was based on findings showing the oral therapy’s efficacy in a pair of randomized, double-blind, placebo-controlled trials involving 3177 adult patients with a history of migraine.

The trials, which included patients both with and without aura history, assessed lasmiditan as treatment post-migraine attack. They showed a significantly greater rate of treated patients had pain and bothersome symptom resolution within 2 hours than those to receive placebo.

Though patients were permitted to take rescue medication following 2 hours of lasmiditan administration, investigators barred the use of opioids, barbiturates, triptans, and ergots within 24 hours of investigative treatment. Almost one-quarter (22%) of patients were taking a preventive medication for migraine at the time of assessment.

Common adverse events in treated patients included dizziness, fatigue, paresthesia, and sedation.

The most common side effects that patients in the clinical trials reported were dizziness, fatigue, a burning or prickling sensation in the skin (paresthesia), and sedation. Clinicians should advise patients to not drive nor operate machinery in the 8 hours following treatment. Lasmiditan also causes central nervous system (CNS) depression, and patients advised to use with caution if taken in combination with alcohol or other CNS depressants.

Approximately one-third of all people who suffer from migraine experience aura—an appearance of flashing lights, zig-zag lines, or a temporary loss of vision. Currently, migraine affects approximately 1 in 10 people worldwide, and is 3 times more common in women than in men.

That prevalence is closer to 1 in 7 Americans, Nick Kozauer, MD, acting deputy director of the Division of the Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. Lasmiditan’s approval adds to the growing market for the common condition.

“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,” Kozauer said.