Reyvow – approved by the FDA and cleared by the DEA

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Drug: Reyvow (lasmiditan)
Manufacturer: Eli Lilly
Condition: For acute treatment of migraine headaches
Approved: Approved October 11, 2019

Eli Lilly’s Reyvow™ (lasmiditan) received FDA approval on Oct. 11, 2019 for the acute treatment of migraine with or without aura in adults. It is the first serotonin receptor agonist to target the 5-HT1F receptor. It has created a new class of drugs, which will be referred to as ‘ditans.’3 ‘Ditans’ differ from triptans in their method of action, triptans are 5-HT(1B/1D) serotonin receptor agonists.

Condition overview4-7

Migraine headaches are common in the United States, affecting nearly 1 out of 7 Americans annually. A migraine is a recurring, severe, throbbing headache that’s usually on one side of the head. Migraine attacks can last for a few hours, or a few days. Other symptoms can include nausea, vomiting, and extreme sensitivity to light and sound. Flashes of light or blind spots may happen before or during the headache. Tingling on one side of your face, or in your arm or leg, can also occur.

One or two days before the migraine, you may have warning signs including constipation, mood changes, food cravings, neck stiffness, increased thirst and urination, and frequent yawning.

Current treatments1-4

Pain-relieving medications. Also known as acute or abortive treatment, these drugs are taken during migraine attacks to stop symptoms.2
Preventive medications. These drugs are taken regularly, sometimes daily, to reduce the severity or frequency of migraines.2
Choice of medicine depends on the frequency and severity of headaches, the degree of disability they cause, and other medical conditions.2 Patients that experience mild symptoms may be treated with over-the-counter pain medications, often used in combination with caffeine.

Acute migraine attacks can be treated with triptans, ergotamine, butalbital combination products, and opioids. Triptans are the current standard of care for acute treatment for moderate to severe symptoms of migraine, and are available in various dosage forms including pills, nasal sprays and subcutaneous injection. Response rates to triptans may decrease over time.2 The new acute migraine treatments like Reyvow and the CGRP receptor agonists, may be recommended after triptans fail or if a patient cannot tolerate a triptan.

Reyvow overview

Reyvow is the first drug in a new class of migraine medications called serotonin-1F receptor agonists, or ditans. It may be used for some migraine patients who cannot take triptans due to the risk of comorbidities, or coronary artery disease, hypertension and stroke. (Triptan’s mechanism of action constricts certain blood vessels.) In clinical trials, Reyvow was found to improve migraine symptoms within two hours compared to placebo, and side effects were generally mild to moderate.

Eli Lilly noted that there is a potential for abuse of Reyvow. The Drug Enforcement Administration (DEA) has completed its controlled substance classification for Reyvow in late January.  The drug will be available to patients in retail pharmacies in early February.5

Drug: Reyvow (lasmiditan)
ROA: Oral
Condition: For acute treatment of migraine headaches
Approved: Approved by the FDA Oct. 11, 2019
Benefit: Reyvow will impact the pharmacy benefit

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References

1. Burch, RC, et al. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. (2015.) – PubMed – NCBI. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25600719

2. Migraine – Symptoms and causes. Mayo Clinic. (April 26, 2017). Retrieved from https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc-20360201

3. Durham P, Vause C. CGRP Receptor Antagonists in the Treatment of Migraine. CNS Drugs. 2010;24(7):539–548.

4. UpToDate. Acute migraine. Literature review current through April 2019. Last updated December 11, 2018.

5. Lilly’s migraine reliever Reyvow cleared for launch, setting up market battle with Allergan’s Ubrelvy | FiercePharma

6. Icer-review.org Acute treatments for migraine: effectiveness and value. Revised Background and Scope July 29, 2019. ICER Institute for clinical and economic review. Accessed in September 2019 at: https://icer-review.org/wp-content/uploads/2019/06/ICER_Acute_Migraine_Revised_Scope_072919-1.pdf)