Reyvow For Acute Migraine Therapy. 2023
Reyvow For Acute Migraine Therapy
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.
Read my Mini Book on Migraine here.
Four out of 5 patients have severe pain during a migraine attack. Migraine is a terribly disabling condition and there is need for acute treatment drugs.
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.
Does Reyvow (lasmiditan) for migraine help? Reyvow (lasmiditan) is the first of a new class of drugs, called a Ditan, for the acute treatment of migraine with or without aura. Migraine involves serotonin metabolism in the brain and drugs that activate serotonin provide headache treatment. 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.
Indication.
Reyvow (lasmiditan) is indicated for the acute therapy of migraine headache. It is not indicated for the preventive treatment of migraine.
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.
Spartan Pain free at 2 hours Samurai Pain Free at 2 hours
50 mg 28% 50 mg 15%
100 mg 31% 100 mg 28%
200 mg 39% 200 mg 32%
Placebo 21% Placebo 15%
Pain Freedom
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For Spartan 39% of patients achieved Pain free at 2 hours for the 200 mg dose.
For Sumuari 32% achieved Pain free at 2 hours for the 200 mg dose.
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Spartan MBS free Samurai MBS free
50 mg 49%
100 mg 44% 100 mg 41%
200 mg 41% 200 mg 41%
Placebo 33% Placebo 30%
MBS FREEDOM
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Adverse Reactions
Adverse Reaction Placebo 50 mg 100 mg 200 mg
Dizziness 3% 9% 15% 17%
Fatigue 1% 4% 5% 6%
Paresthesia 2% 3% 7% 9%
Sedation 2% 6% 6% 7%
Nausea/vomiting 2% 3% 4% 4%
Weakness 0% 1% 1% 2%
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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.
Pediatric 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.
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).
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 with patients with migraine who over treat their headaches with analgesics more than 2 days a week. The patient may develop very frequent or daily headaches with migraine features.
The treatment of medication overuse headache is patient education and drug withdrawal.
Editor comments.
Hopefully, this new drug will not cause problems with patients with cardiovascular diseases such as uncontrolled hypertension, stroke, TIA, coronary heart disease or post myocardial infarct patients, all possible drug side effects for persons who take triptans for Migraine treatment.
Preliminary results would indicate that drugs which impact serotonin are usually okay with cardiovascular patients.
There is a concerning limit of driving activity of 8 hours after dosing which may turn out to be a limiting treatment problem.
The successful results of Reyvow (lasmiditan) are about half of the success rates of triptans so many patients who can successfully take triptans will stay with them.
But for the triptan non-responder group, and the cardiovascular limited patients, Reyvow (lasmiditan) may be just what the doctor ordered—another useful drug in the doctor’s black bag to treat migraine.
Check out my Big Book on Migraine Here.
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All the best.
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Britt Talley Daniel MD