FDA approves Reyvow (lasmiditan) for Migraine with or without aura

Move over, triptans. The US Food and Drug Administration has approved a new acute therapy for Migraine with or without aura in adults. Reyvow (lasmiditan) is an oral medication, unlike other recent entries in the acute Migraine category.


Reyvow has been approved for acute use of Migraine with or without aura in adults. It’s designed to relieve the pain of an attack, like triptans.

On January 31, 2020, the manufacturer of Reyvow, Eli Lilly, announced that the drug is now available by prescription and will be in pharmacies across the U.S. within the next few days. It is available in three doses- 50-mg, 100-mg, and 200-mg ( ).

A New Class of Migraine Medication

Triptans have been the acute Migraine treatment since they hit the market in the 1990s. Triptans are a class of drugs called selective 5-HT agonists. While pharmaceutical companies have made strides with different delivery methods for triptans, there hasn’t been a new oral Migraine med designed to abort an attack – until now.

Reyvow belongs to a new class of meds called ditans, and it is the only medication in this class to be approved. Reyvow is a 5-HT 1F receptor agonist, and it is believed to act both centrally and peripherally on the nervous system ( ).

A Viable Relief Option for People with Heart Problems

Eli Lilly, which acquired CoLucid Pharmaceuticals in 2017, announced on October 11, 2019, the FDA approval of a new Migraine med called Reyvow (lasmiditan) ( ). Like triptans, lasmiditan is a 5-HT agonist, but with one important difference: it does not constrict the blood vessels.


Dr. Peter Goadsby, AHS Scientific Program Committee Chair, Professor of Neurology and Director of NIHR-Wellcome Trust King’s Clinical Research Facility at King’s College Hospital, London, explained:

“There’s no contraindication or issue for people with heart problems or stroke, for example, because lasmiditan doesn’t touch vessels. It doesn’t do any vasoconstriction, so all of that goes away,” Goadsby told Migraine Again Managing Editor Paula K. Dumas at the American Headache Society’s (AHS) 59th Annual Scientific Meeting in June 2017.

New Hope for Two-Thirds of People with Migraine Who Don’t Respond to Triptans, Says Dr. Peter Goadsby

Heart disease is comorbid with Migraine, meaning the two often occur together. A new Migraine medication that is safe for people with heart disease has the potential to help a significant number of people.

The value of an acute Migraine treatment that is able to get rid of Migraine pain within two hours cannot be overstated. People with Migraine who have not had success with triptans, either because of contraindications like heart disease, bothersome side effects, or because triptans simply didn’t work, have new hope with lasmiditan.

“Two-thirds of people who take a triptan now, they’re not pain-free in two hours. That’s a lot of people. So while the triptans were a fantastic development [and] did a lot of good, I sometimes think people forget that one third is a small number compared to two thirds,” said Dr. Goasdby. “People who have side effect problems with triptans and contraindications with triptans, they should be optimistic, because lasmiditan is going to take some of those away.


Reyvow strengthens Eli Lilly’s migraine portfolio with an acute therapy to complement its CGRP preventive therapy, Emgality. Emgality is approved to prevent cluster headaches and to prevent Migraine in adults.

The company must be pretty optimistic about the drug’s potential since they paid nearly $1 Billion to acquire it from CoLucid. That’s almost a dollar for every person with Migraine around the world.

Studies show lasmiditan is an effective new Migraine medication

The FDA approval of Reyvow is based on 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.

Both studies measured the percentage of patients who were pain-free and free of their most bothersome symptom (nausea, light sensitivity, or sound sensitivity) within two hours of treatment. Participants were allowed to take a rescue medication two hours after taking Reyvow, but opioids, triptans, and ergots were not allowed within 24 of participating in the study.

In both trials, a significantly greater percentage of patients experienced relief with Reyvow at all doses compared to those receiving the placebo. It’s worth noting that 22% of participants were also taking preventative medication for Migraine.


According to Dr. Goadsby, lasmiditan studies included both people with Migraine without aura and people with Migraine with aura. The studies show lasmiditan is safe and effective for both Migraine types.

Reyvow Side Effects: FDA Warns It May Affect Ability to Drive

The most common side effects noted in studies were dizziness, vertigo, paresthesia (pins and needles feeling), and fatigue ( ).

The FDA warns that your ability to drive may be impaired while taking Reyvow, and advises patients not to drive for at least 8 hours after taking it.

The safety information for Reyvow includes the following warning:

REYVOW may cause significant driving impairment. In a driving study, administration of single 50 mg, 100 mg, or 200 mg doses of REYVOW significantly impaired subjects’ ability to drive. Additionally, more sleepiness was reported at 8 hours following a single dose of REYVOW compared to placebo. Advise patients not to engage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle or operating machinery, for at least 8 hours after each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Prescribers and patients should be aware that patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW ( ).

Reyvow Comes with Medication Overuse Risk

Like with NSAIDs, opiates, and triptans, this new Migraine medication comes with the potential for Medication Overuse Headache. To avoid this secondary headache disorder, try not to take Reyvow more than 2-3 days per week The most common side effects noted in studies were dizziness, vertigo, paresthesia (pins and needles feeling), and fatigue ( ).

Reyvow Comes with a Risk for Serotonin Syndrom

Alarmingly, some participants in clinical trials had reactions to Reyvow consistent with serotonin syndrome – even when they were not taking another drug associated with serotonin syndrome. From the press release ( ):

Serotonin syndrome may also occur with REYVOW during coadministration with serotonergic drugs [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (e.g., hyperreflexia, incoordination), and/or gastrointestinal signs and symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue REYVOW if serotonin syndrome is suspected.

How Much Does Reyvow Cost?

Eli Lilly announced that the list price for a package of eight tablets is $640 ( ). This does not mean that is what you will pay at the pharmacy. Depending on your insurance overage and/or eligibility for the savings card, you could pay much less.


A Reyvow savings card could allow you could pay as little as $0 per month for up to 12 months, if you’re eligible and have commercial insurance. Like with other savings plans, those with Medicaid or Medicare are excluded. See Reyvow’s website for more info.

Read Lilly’s January 31st press release on Reyvow.

When Will Reyvow (lasmiditan) Become Available?

If you are one of the many people without a reliable abortive medication for your migraine attacks, rest assured: new, exciting things are on the horizon. The Migraine community has been waiting for more than two decades for a big innovation in acute treatment. The wait, finally, is over.

We can expect to see Reyvow in pharmacies beginning the first week of February. Reyvow is available by prescription only in the US, although we hope other countries will follow suit soon. Talk to your doctor about whether this option is right for you. Talk to your doctor about a prescription.

Updated February 3, 2020 with cost

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