The US Food and Drug Administration has approved Reyvow (lasmiditan) tablets for acute migraine with or without aura in adults.

"Reyvow 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, FDA Center for Drug Evaluation and Research, said in a release.

"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," he added.

The FDA approval of Reyvow is based on efficacy data from two randomized, double-blind, placebo-controlled trials. A total of 3177 adults with a history of migraine with or without aura took Reyvow to treat a migraine attack in these studies.

In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom, such as nausea, light sensitivity, or sound sensitivity, resolved 2 hours after treatment were significantly greater in those receiving Reyvow at all doses compared with placebo.

Although patients were allowed to take a rescue medication 2 hours after taking Reyvow, opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of the study drug administration. Twenty-two percent of patients were taking a preventive medication for migraine.

The FDA warns that driving ability may be impaired while taking Reyvow. Patients are advised not to drive or operate machinery for at least 8 hours after taking the drug, even if they feel well enough to do so.

Patients who cannot follow this advice are advised not to take Reyvow. The drug causes central nervous system (CNS) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants.

The most common side effects reported by patients in the clinical trials were dizziness, fatigue, a burning or prickling sensation in the skin (paresthesia), and sedation.

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