On Friday, the U.S. Food and Drug Administration (FDA) approved a new medication to treat acute migraine with or without aura called Reyvow. According to its manufacturer, Eli Lilly, Reyvow is the first in a new class of drugs to treat acute migraine symptoms.
The FDA announced it approved Reyvow (generic name lasmiditan) to treat acute migraine symptoms in adults based on the results of two randomized, double-blind, placebo-controlled clinical trials that included over 3,000 participants. According to the FDA, the results of the clinical trials demonstrated that many patients experienced relief from their migraine symptoms like nausea and light sensitivity within two hours of taking Reyvow.
According to the American Migraine Foundation, migraine is defined as five or more lifetime migraine attacks that last for 4-72 hours and interrupt your daily routine. Migraine can cause severe head pain, but also other symptoms such as nausea, light sensitivity or sound sensitivity. You may also experience aura symptoms, like vision issues, prior to the onset of head pain. About 10% of the world’s population experience migraine.
While the FDA found patients taking Reyvow improved “significantly” compared to those taking the placebo, 22% of study patients were also taking a preventative migraine drug, which could have impacted the results of the trials. Patients in the study could also use a rescue medication two hours after taking Reyvow if their symptoms didn’t sufficiently improve, but not opioids, barbiturates, triptans or ergots. Eli Lilly said Reyvow is the first serotonin (5-HT)1F receptor antagonist drug, which previous research suggests may block migraine.
Reported side effects of taking Reyvow include potential impairment while driving. The FDA recommended you should not drive or operate heavy machinery for at least eight hours after taking Reyvow. Because the drug depresses or slows down your central nervous system, you may also experience dizziness, sedation, tingling or numbness on your skin, nausea or muscle weakness. About 1% of clinical trial participants experienced hallucinations while taking Reyvow.
According to an Eli Lilly press release, additional mandatory studies determined Reyvow had more “abuse potential” than a placebo but less so than alprazolam (brand name Xanax). Alprazolam does carry a risk for dependence and is classified by the Drug Enforcement Administration (DEA) as a schedule IV controlled substance (out of V). Reyvow will be evaluated and scheduled by the DEA within 90 days because it may have a higher risk for misuse.
Reyvow is taken in tablet form by mouth. According to an Eli Lilly spokesperson, the pharmaceutical company has not yet set a price for the medication. The cost will vary depending on your insurance and other factors, and Eli Lilly will create a patient support program for the drug. Reyvow will be available to the public starting in January 2020.
“The price will be determined closer to the time of commercial availability,” an Eli Lilly spokesperson told The Mighty via email. “Lilly is confident in the value of REYVOW for people living with migraine and will determine a value-based price that encourages access to this new and novel treatment.”
Earlier this year the FDA approved the medication Emgality (generic name galcanezumab) to treat cluster headaches. In 2018, the FDA approved two new anti-CGRP migraine prevention drugs: Avjoy and Amivog.
“Reyvow is a new option for the acute treatment of migraine,” said Nick Kozauer, M.D., acting deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research in a press 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.”
Article updated Oct. 12, 2019