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REYVOW Approved for Acute Treatment of Migraine

October 15, 2019
The medication becomes first approved in new serotonin-1F (5-HT1F) receptor agonists class of medications.

A PPM Brief

Eli Lilly (Indianapolis, IN) have announced1 FDA-approval of REYVOW (lasmiditan), an oral medication for the acute treatment of migraine with or without aura in adults. To date, REYVOW is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin-1F [5-HT1F] receptor agonists).

The NDA for REYVOW includes data from two Phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the drug’s safety and efficacy. Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom (patient selected from nausea, sensitivity to light, or sensitivity to sound) at two hours following administration of REYVOW in comparison to placebo. Treatment emergent adverse events were mild and the most frequent included dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness. The overall REYVOW Phase 3 development program involved more than 4,000 patients and the treatment of more than 20,000 migraine attacks.

The FDA approval of REYVOW marks the first new class of acute migraine treatment approved in more than two decades. (Image: iStockPhoto)

“New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them,” said Gudarz Davar, MD, vice president of neurology development at Lilly, in the company’s press release.

Lilly conducted a human abuse potential assessment where therapeutic doses of REYVOW were associated with less drug liking when compared to alprazolam, but more than placebo. The recommended controlled substance classification for REYVOW is currently under review by the DEA and is expected within 90 days following the announcement of this FDA approval.

“Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like REYVOW is an important development for physicians and the patients we treat,” said Jan Brandes, MD, MS, FAAN, assistant clinical professor at the Department of Neurology at Vanderbilt University in Nashville, TN, in the Lily press release.

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

Last updated on: October 15, 2019
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