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FDA Approves Reyvow Tablets To Treat Migraine

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The U.S. Food and Drug Administration or FDA approved Reyvow (lasmiditan) tablets of Eli Lilly and Co. as an oral medication for the acute treatment of migraine, with or without aura, in adults. However, Reyvow is not indicated for prevention of migraine.

Reyvow is a new oral treatment that binds to 5-HT1F receptors with high affinity. The approval of it is the the first new class of acute migraine treatment approved by the agency in more than two decades.

Migraine is a neurologic disease characterized by recurrent times of intense throbbing or pulsing pain in one area of the head, accompanied by nausea and/or vomiting and sensitivity to light and sound.

One in seven Americans or 30 million adults are affected by it - three times more women than men suffering from the disease.

The effectiveness of Reyvow was demonstrated in two randomized, double-blind, placebo-controlled trials conducted on a total of 3,177 adult patients with a history of migraine.

Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom such as nausea, light sensitivity, or sound sensitivity at two hours following administration of Reyvow in comparison to placebo.

The recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration (DEA). The approval is expected within 90 days of FDA approval, after which Reyvow will be available to patients in retail pharmacies.

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