Articles

A New & Hopeful Era of Care for People with Headache Diseases

By Kevin Lenaburg, Executive Director, Coalition for Headache and Migraine Patients (CHAMP) and William B. Young, MD, FAHS, FAAN, FANA, and Medical Advisor, CHAMP

The headache community has entered a revolutionary phase that is transforming the disease burden for people living with headache disorders. The growing diversity and number of new medicines and devices to treat migraine, cluster, and other headache diseases means there are more tools in the treatment toolbox.

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; and 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 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 following tables show the recent innovative treatment options that have come out for migraine.

Migraine preventive treatments

Medicines that can be taken on a regular schedule to reduce the intensity and frequency of migraine attacks. Botox ® (onabotulinumtoxinA) was also approved by the FDA in 2010 as a preventive treatment for chronic migraine.

Migraine acute treatments

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

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 (eneura.com) with its 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. 

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

Innovative Cluster Headache Treatments

  • Emgality
    CGRP-inhibitor approved for the treatment of episodic cluster headache. Note the dosage for cluster headache is different than for migraine. For cluster, the regimen is 300 mg (three injections of 100 mg given back-to-back-to-back) at the start of the episodic cluster cycle and then continue to take 300 mg monthly until the cluster cycle is over.
  • gammaCore Sapphire
    Device cleared by the FDA for the treatment of cluster headache. For prevention, regimen is using device in morning and night, giving 3 two-minute stimulations per session. For acute relief of cluster headache, regimen is using device for 3 two-minute stimulations at the onset of pain, and then if pain persists, wait 3 minutes and do another 3 two-minute stimulations. Up to 24 stimulations allowed per day.

What’s under development in the migraine pipeline

Near-Term

Trudhesa

  • Nasal formulation of dihydroergotamine (DHE) 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

Pituitary Adenylate Cyclase-Activating Peptide (PACAP)

  • Investigating compounds that would inhibit this protein that is 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

  • The active ingredient in “magic mushrooms” has been 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 needs to be done before this could become an FDA-approved medicine.

Financial Assistance

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.