NeurologyLive® Top Stories of 2021: Headache & Migraine

In 2021, migraine and headache specialists continued to be at the benefit of a robust, and constantly evolving drug development space, which was headlined by several notable approvals. As the news broke, the NeurologyLive® team worked to provide top-level coverage for the clinical community, as well as voicing the opinions of those who understand the diseases best themselves.

Treatment optimization and the ability to perfectly craft the right medication formulae for a patient has been a top priority among clinicians as their toolbox continues to expand. Additionally, a number of new agents have made their way to the market, offering more opportunities for clinicians to optimize treatment and find agents that work for their patients.

In a year that saw such immense progress, NeurologyLive® was there to cover the top news. To read more about relevant news in migraine and headache, hear experts share insight on top discussions in the field, and learn more about the ongoing conversations, head to our headache and migraine clinical focus page.

Click the buttons below to learn more about each story.

1. Atogepant Approved for Episodic Migraine Prevention

In September, AbbVie’s atogepant (Quilipta) joined rimegepant as the second CGRP receptor of the gepant class to be FDA-approved for the preventive treatment of episodic migraine. Data from a clinical program evaluating the efficacy, safety, and tolerability of the drug in almost 2000 patients with episode migraine, led to the decision. One of the studies, the pivotal phase 3 ADVANCE study (NCT02848326), included 873 patients with episodic migraine who were randomized 1:1:1:1 to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks.^1,2

In ADVANCE, atogepant demonstrated an ability to improve several prespecified, multiplicity-controlled secondary end points across the 12-week period. At the time of the approval, Jessica Ailani, MD, FAHS, director, MedStar Georgetown Headache Center, and investigator in the atogepant clinical trials, told NeurologyLive®in an interview, “Atogepant provides a disease specific option for migraine prevention that is effective and well-tolerated in clinical trials. With FDA approval, clinicians will now have the opportunity to see where atogepant may separate from other therapies in practice and, hopefully, the field will take another step towards migraine freedom."

Although a major moment, atogepant’s approval was not the first of the year for those in the field of migraine care. In May, the FDA approved the aforementoned rimegepant (Nurtec ODT; Biohaven) for the preventive treatment of migraine, adding to its prior indication for the acute treatment of the headache disorder, and marking it as the first oral calcitonin gene-related peptide (CGRP) antagonist to be approved for prevention and the first to be approved for both acute and preventive therapy.³

Rimegepant isn’t the only medication that made headlines this year, including the FDA approval of NeuroPharma’s INP104 nasal spray,⁴ and the first approved oral solution of topiramate to treat epilepsy and migraine.⁵

2. Relivion Noninvasive Neuromodulation System Cleared for Acute Migraine

The Relivion system, a noninvasive multichannel brain neuromodulation system, was cleared by the FDA for the at-home treatment of acute migraine in adults in early January. Placed on top of patients’ head, the device targets 6 branches of the occipital and trigeminal nerves, releasing neurotransmitters in the brainstem and modulating the networks associated with pain.⁶

Data from the pivotal international RIME trial, which included 131 patients who met the criteria of migraine with or without aura, was the basis for the approval of Neurorelief’s system. This prospective, double-blind, placebo-controlled trial showed that 46% of those in the treatment group achieved complete pain freedom at 2-hours post-treatment compared to only 11.8% in the control group.⁷ Stewart J. Tepper, MD, professor of neurology, Geisel School of Medicine, Dartmouth, told NeurologyLive® at that time that "the device combines neuromodulation of bilateral greater occipital nerves, supraorbital, and supratrochlear nerves, and this combination of inhibitory neuromodulation appears synergistic. Providers can look forward to access for another effective nondrug therapy for acute treatment of migraine."

Devices have been a hot topic in migraine care over the last several years as patients have continued to be faced with refractory disease despite novel pharmacologic options becoming available. In the same month the Relivion system was approved, the FDA approved Theranica’s Nerivio for acute treatment of migraine in adolescents, just 2 years after it was listed among TIME's best inventions of 2019.⁸ The device is worn on the upper arm for 45 minutes, and utilizes Remote Electrical Neuromodulation to activate the brain's native conditioned pain modulation mechanism to treat pain and associated symptoms of migraine.

3. Lifestyle Change for Migraine Management: Practical Tips for the Neurologist and PCP

In early August, Stephen Silberstein, MD, and William B. Young, MD, authored a piece that highlighted the need to focus on proactive lifestyle behavior changes that will help improve migraine aside from the typical medication. Increased amounts of research in recent years have backed the idea that consistent health behaviors will reduce migraine severity and attack frequency.

Silberstein, professor director of the Jefferson Headache Center, and Young, codirector of the Inpatient Program at the Jefferson Headache Center, have been headache specialists for over 30 years. They address 3 of the 6 categories of lifestyle changes, including sleep, hydration, and nutrition. In part 1 of the 2-part series, the duo outline the most important aspects patients should be focus on to improve their migraine management while still on their daily medication.

That pairing were also not the first to bring up the need for better lifestyle management of migraine, as Valentina Popova, MD, pediatric headache specialist, NYU Langone, discussed the lifestyle choices children and parents must make to ensure optimal management of pediatric migraine with NeurologyLive® a month earlier, in July. Popova explained that doing things as simple as "eating breakfast in the morning with some protein is important to try to prevent migraines throughout the day,” adding that "hydrating and drinking an adequate amount of water is important as well. For an adult, it’s about 8 to 10 cups a day, but in kids it depends on how big they are. We talk to the kids and parents to individualize this."

REFERENCES

1. FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine. News release. AbbVie. September 28, 2021. Accessed September 28, 2021. https://news.abbvie.com/news/press-releases/fda-approves-qulipta-atogepant-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-preventive-treatment-migraine.htm?view_id=1531

2. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021; 385:695-706. doi:10.1056/NEJMoa2035908
3. FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment. News release. May 27, 2021. Accessed December 21, 2021. https://www.prnewswire.com/news-releases/fda-approves-biohavens-nurtec-odt-rimegepant-for-prevention-now-the-first-and-only-migraine-medication-for-both-acute-and-preventive-treatment-301301304.html
4. Impel NeuroPharma announces US FDA approval of Trudhesa (Dihydroergotamine mesylate) nasal spray for the acute treatment of migraine. News release. Impel NeuroPharma. September 3, 2021. Accessed December 21, 2021. https://www.biospace.com/article/releases/impel-neuropharma-announces-u-s-fda-approval-of-trudhesa-dihydroergotamine-mesylate-nasal-spray-for-the-acute-treatment-of-migraine/

5. Azurity Pharmaceuticals announces FDA approval of Eprontia (topiramate) oral solution. News release. Azurity Pharmaceuticals. November 8, 2021. Accessed December 21, 2021. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-eprontia-topiramate-oral-solution/
6. Relivion® Wearable Brain Neuromodulation Technology Cleared by FDA for the Treatment of Migraine. News release. March 2, 2021. Accessed December 21, 2021. https://www.biospace.com/article/releases/relivion-wearable-brain-neuromodulation-technology-cleared-by-fda-for-the-treatment-of-migraine

7. Neurolief Announces Positive Results From RIME Clinical Study of Its Brain Neuromodulation System for Treating Acute Migraine. January 6, 2021. Accessed December 21, 2021. https://www.businesswire.com/news/home/20210106005510/en/Neurolief-Announces-Positive-Results-From-RIME-Clinical-Study-of-Its-Brain-Neuromodulation-System-for-Treating-Acute-Migraine
8. FDA approves Theranica’s Nerivio for acute treatment of migraine in adolescents. News release. January 25, 2021. Accessed December 21, 2021. https://www.prnewswire.com/news-releases/fda-approves-theranicas-nerivio-for-acute-treatment-of-migraine-in-adolescents-301213967.html