A Hopeful New Era for Headache Treatments

Now is a time of much hope for people living with headache diseases. It’s no accident that the 2021 theme for the National Migraine & Headache Awareness Month is A New Era of Care. The growing diversity and number of new headache treatments, medicines and devices to treat migraine, cluster, and other headache diseases means there are more tools in the treatment toolbox. For people who live with the pain and disability of having a headache disease, this is a time unlike any before it.

The headache community has entered a revolutionary phase that is transforming the disease burden for people living with headache disorders.

Thriving with Better Headache Treatments

The challenge is that even with so many new treatment options, many people who experience migraine and other headache diseases continue to settle for treatments that sort of work. All too often, patients share, “My medications work for me somewhat and sometimes, and that is better than nothing.”

Patients are surviving with mediocre treatments when they could be thriving with better treatments. The headache community must change the paradigm for acceptable care. Settling for so-so can’t continue to be the norm. The responsibility for change falls on all our shoulders. Health care providers must commit to finding the best possible treatments for each patient. Patients must continue to advocate for themselves.

While we push for better care for all with headache diseases, we also acknowledge that for chronic and intractable migraine and cluster patients, it can be especially challenging to find the right mix of treatments to effectively manage their headache disease.

There are many medications that patients have used to treat migraine and headache diseases for decades, and for many patients these should continue to be used. The below tables show the recent innovative treatment options that have come out for migraine.


Special thanks to the Association of Migraine Disorders for creating these tables and allowing them to be adapted  for this article.

Migraine Preventive Treatments

Medicines taken on a regular schedule to reduce the frequency and intensity of migraine attacks. Botox® (onabotulinumtoxinA) is another treatment (not shown in table below) that was approved by the FDA in 2010 as a preventive therapy for chronic migraine.

Brand NameAIMOVIG™AJOVY™
EMGALITY™VYEPTI™
*Nurtec ODT™
Generic Name
erenumab-aooe
fremanezumab-vfrm
galcanezumab-gnlm
eptinezumab-jjmr
rimegepant
Manufacturer
Amgen/Novartis
Teva Pharmaceuticals
Eli Lilly & Company
LundbeckBiohaven Pharmaceuticals
Savings Program
aimovig.com/paying-for-aimovigajovy.com/savingsemgality.com/savingsvyepti.com/savings-and-supportnurtec.com/savings-support
Dosage70 mg or 140 mg once monthly225 mg monthly or 675 mg every 3 months240 mg loading dose then monthly 120 mg doses100 mg infusion every 3 months. Some patients may benefit from a 300 mg dose75 mg taken once every other day
Delivery Administration
Monthly subcutaneous injectionMonthly or quarterly subcutaneous injectionMonthly subcutaneous injectionQuarterly intravenous infusionOrally dissolving tablet

*Nurtec ODT has received FDA approval for prevention as well as acute use for migraine.

Migraine Acute Treatments

Medicines taken at the onset of symptoms to stop or shorten a migraine attack.

Brand NameUbrelvy™*Nurtec ODT™REYVOW™
Generic Nameubrogepantrimegepantlasmiditan
ManufacturerAllergan/AbbVieBiohaven PharmaceuticalsEli Lilly & Company
Savings Programubrelvy.com/savingsnurtec.com/savings-supportreyvow.com/savings-support
Dosage50 or 100 mg, as needed. Max dose is 200 mg in a 24-hr period75 mg, as needed. Max dose is 75 mg in a 24-hr period50,100 or 200 mg, as needed. Max dose is one dose in a 24-hr period
Delivery AdministrationOral tabletOrally dissolving tabletOral tablet

*Nurtec ODT has received FDA approval for prevention as well as acute use for migraine.

Devices

These are FDA-cleared, noninvasive, drug-free medical devices for the acute and preventive treatment of migraine and cluster headache. A fifth company, not in the chart below, is eNeura with their SAVI™ and sTMS mini™ devices that are FDA-cleared for the acute and preventive treatment of migraine in adults and adolescents (12 and older). These neuromodulation devices deliver a brief magnetic pulse to the brain to switch off and prevent migraine attacks.

Brand Name
CEFALY®
Nerivio®
gammaCore Sapphire™
Relivion®*
Manufacturer
CEFALY
Theranica
electroCore
Neurolief
Indication
for patients 18+ unless otherwise explained
Acute and preventive treatment of migraine
Acute treatment of episodic or chronic migraine. Cleared for adolescents 12 years and older
Acute and preventive treatment of migraine. Cleared for  adolescents 12 years and older. Preventive treatment of cluster headache and acute for episodic cluster headache
Acute treatment
of migraine
Price & Savings Program
cefaly.com
nerivio.com
gammacore.com
neurolief.com
Delivery Administration
On forehead. Acute: 60 minutes at onset or during migraine.
Preventive: 20 minutes daily
Start within 1 hour of migraine onset on outer upper arm. Set intensity to a level that is strong but not painful and keep it at that setting for the 45-minute treatment
Acute: Two 2-minute stimulations at symptom onset, on neck. Can be repeated 20 minutes and 2 hours from start of 1st treatment.
Preventive: 3 treatments (morning, mid-day and night) consisting of 2 consecutive 2-minute stimulations daily
The system consists of 3 components—the Relivion headset that delivers the stimulation, the patient app that tracks the migraine attacks and treatment, and the Physician Management Interface that allows for remote monitoring

*Relivion is currently FDA-cleared as a migraine abortive and they are in clinical trials for a preventive indication. It’s expecting a limited release in fall 2021, with full release on the market first quarter 2022.

Financial Assistance for Headache Treatments

Patients with migraine deserve to live a better life. And cost should not be a barrier. The Patient Advocate Foundation’s Migraine Careline provides assistance with navigating eligibility and enrollment in disability benefits and overcoming insurance coverage and financial burdens that impact access to care. For assistance, visit patientadvocate.org/migrainematters or call 1-866-688-3625.


What’s Under Development in the Migraine Pipeline

Near-Term Headache Treatments

Trudhesa

    • Nasal formulation of dihydroergotamine delivered by a special device to the vascular-rich upper nasal space, from Impel NeuroPharma.

Qtrypta

    • Skin patch with microneedle system that delivers zolmitriptan, from Zosano Pharma.

AXS-07

    • Oral medicine with rapid and long-lasting effect that is a combination of rizatriptan and meloxicam, a nonsteroidal anti-inflammatory, from Axsome Therapeutics.

Atogepant

    • Oral anti-CGRP medicine developed specifically for migraine prevention, from Allergan / AbbVie.

Zavegepant

    • Anti-CGRP molecule that is being developed in both oral and intranasal formulations, from Biohaven Pharmaceuticals.

Longer-Term Headache Treatments

Pituitary Adenylate Cyclase-Activating Peptide

    • Investigating compounds to inhibit this protein found in increased levels during spontaneous migraine attacks.
    • Researchers are trying to prove that this may work in patients who do not respond to CGRP medications.
    • Preventive or acute therapy.

Delta Opioid Receptor Agonists

    • Type of opioid that would decrease chronic pain. It differs from Mu opioids that are the currently available opioid medicines.
    • A novel way of treating pain pathways.

Psilocybin 

    • Active ingredient in magic mushrooms used by many people battling cluster headache.
    • Recent studies from Yale have documented the efficacy of psilocybin in preventing cluster headaches and migraine attacks.
    • Lots more research, clinical trial and regulatory work needed before this could become an FDA-approved medicine.

Innovative Cluster Headache Treatments

Emgality

  • This CGRP-inhibitor is approved by the FDA for the treatment of episodic cluster headache. Important to note that the dosage for cluster headache is different than the recommended dosage for migraine. For cluster headache the regimen is 300 mg (three injections of 100 mg each) at the start of the episodic cluster cycle and then continue to take 300 mg monthly until the cluster cycle is over.

gammaCore Sapphire

  • This device is cleared by the FDA for the prevention and acute treatment of cluster headache.
  • For prevention, the recommended regimen is to use gammaCore Sapphire in both the morning and night, giving 3 2-minute stimulations per session.
  • For the acute relief of cluster headache pain, the recommended regimen is to use gammaCore Sapphire for three 2-minute stimulations at the onset of pain, and then if pain persists, wait 3 minutes and then do another 3 2-minute stimulations.

Written by:

headache treatments

 

 

Kevin Lenaburg
Executive Director
Coalition for Headache and Migraine Patients

 

 

headache treatments

 

 

William B. Young, MD, FAHS, FAAN, FANA
Professor, Department of Neurology, and Co-Director, Headache Center Inpatient Program, at the Thomas Jefferson University Hospital
Board President and Medical Advisor, CHAMP

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