Migraine is a complex neurovascular entity which is genetic, affects 25% of women and 6% of men, is disabling, and may be either episodic or chronic in occurrence.  12% of  the world’s population have migraine.

Four out of 5 patients have severe pain during a migraine attack.

Migraine has to do with serotonin metabolism in the brain and drugs that activate serotonin would provide treatment of Migraine..

This is an article by Britt Talley Daniel MD, member of the American Academy of Neurology, the American Headache Society, migraine textbook author, and blogger.

Read my eBook on Migraine Here.

Reyvow For Migraine.  The FDA has released Reyvow (lasmiditan), the first and only Ditan for the acute treatment of migraine with or without aura.  Reyvow (lasmiditan) may be used for triptan non-responders or persons with clinical conditions limiting triptan use.

Reyvow (lasmiditan) is classified as a serotonin (5-HT) 1F receptor agonist.  An agonist is a chemical that binds to a receptor and activates the receptor to produce a biological response.  Reyvow (lasmiditan) activates the release of serotonin, which helps migraine headache.

Related questions.

Site of activation.

Reyvow (lasmiditan) binds with high affinity to the 5-HT1F receptor and is believed to act in the brain centrally and peripherally.

Dosing  Three oral dose sizes of Reyvow (lasmiditan) exist-50, 100, and 200 mg.

Reyvow (lasmiditan) may be taken with or without food.

Only 1 dose should be taken in 24 hours.

A second dose of Reyvow (lasmiditan) is not effective for the same migraine attack.

The safety of treating more than 4 migraine attacks in 30 days has not been established.

What were the research trials that showed effectiveness of Reyvow (lasmiditan)?

There were 2 trials called Spartan and Samurai.

The trials looked at “Pain Freedom” and “MBS.”

MBS refers to migraine symptoms of photophobia, phonophobia, or nausea.

The two trial results are shown on the tables below.

The most common adverse reactions (>/=) 5% were dizziness, fatigue, paresthesia, and sedation.

Reyvow (lasmiditan) drug contraindications.

It may further lower heart rate when given to patients with heart rate lowering drugs.

It should not be used with P-gp and Breast Cancer Resistant Protein (BCRP) substrates.

Use in Specific Populations.

Pregnancy.  There is no adequate data on the use of Reyvow (lasmiditan) in pregnant women.  It may cause fetal harm-study based on animal data.

Lactation.  There is no data on the presence of Reyvow (lasmiditan) in breast milk and consideration of side effects should be balanced with possible benefit from use.

Severe hepatic impairment.  It has not been used in patients with severe hepatic impairment.

Pediatric use-there is no safety or effectiveness data.

Geriatric use.  Dizziness occurred more commonly in persons over 65 years old and related to a dose effect.  The lowest effective dose of Reyvow (lasmiditan) should be used.

Other side effects

Dizziness, paresthesia, fatigue, nausea, vomiting, muscle weakness, hypersensitivity reaction, decreased heart rate and increased blood pressure are other possible side effects.

Contraindications

Driving within 8 hours of dosing.

Caution if used with another CNS depressor.

Caution in elderly patients.

Caution with alcohol use.

Important safety information.

A single dose of Reyvow (lasmiditan) may cause significant driving impairment due to increased sleepiness lasting as long as 8 hours.

Therefore, because of this possible side effect patients are advised to not perform 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 (lasmiditan).

However, sedation in one review only occurred in 9% of patients.  Sedation doesn’t occur that often. The sedation response is not that much worse comparing the 100 mg with the 200 mg dose. Sedation is drug dose dependent and may be improved by using the lowest dose-50mg.

The product information sheet stresses that patients who cannot follow the 8 hour non-driving recommendation, shouldn’t take Reyvow (lasmiditan).

Prescribing physicians of Reyvow (lasmiditan) should also stress this non-driving for 8 hours after dosing point.

Reyvow (lasmiditan) is a Schedule V controlled Substance.

In a human abuse potential study subjects gave higher “liking scores” for Reyvow (lasmiditan) than placebo indicating it has abuse potential.

However, the amount of liking was less than for alprazolam, a class four narcotic, for treatment of anxiety.

Feelings of euphoric mood and relaxation were reported with use of Reyvow (lasmiditan).

No physical withdrawal was observed in healthy subjects following abrupt cessation of Reyvow(lasmiditan) after seven daily doses of 200 mg or 400 mg.

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Warnings and precautions.

CNS depression.  Reyvow (lasmiditan) may cause central nervous system (CNS) depression, sedation, and dizziness.  It should be used with caution with alcohol or other CNS depressants.

Serotonin syndrome.  Reyvow (lasmiditan) caused reactions consistent with serotonin syndrome in clinical trials.  Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular sings, and/or gastrointestinal signs and symptoms. 

The onset of serotonin syndrome symptoms was within minutes to hours after receiving a new or greater dose of a serotonergic drug.

Medication overuse headache.  This is a problem, usually with patients with migraine, who overtreat their headaches with drugs more than 2 days a week.  The patient may develop very frequent or daily headaches with migraine features.  This can also happen if a Migraine patient takes more than Reyvow more than 10 days per month.

The treatment of medication overuse headache is patient education and drug withdrawal.  See my articles at www.doctormigraine.com on this subject.

Summary

Reyvow is another, useful drug to add to the headache neurologist’s armory to treat Migraine.

Read my big book on Migraine Here.

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All the best.

Follow me at:  www.doctormigraine.com, Pinterest, Amazon books, podcasts, and YouTube.

Britt Talley Daniel MD