GammaCore nVNS Cleared for Paroxysmal Hemicrania and Hemicrania Continua

The FDA has cleared an expanded indication for electroCore’s gammaCore noninvasive vagus nerve stimulation (nVNS) to treat patients with paroxysmal hemicrania (PH) and hemicrania continua (HC) in adults, making it the first treatment—drug or device—to be approved for these patient populations.¹

Data from multiple clinical audits and case series/case reports that included patients with PH or HC were the basis for the label expansion. Among a cohort of 14 patients with PH and 19 patients with HC, 79% of those experienced clinically meaningful benefits from the device for each indication. This included decreases in the severity of persistent pain and/or reductions in the frequency, severity, and/or duration of attacks. Notably, many patients reported at least 1 clinical benefit and no serious or unexpected adverse events occurred as well.¹

"Paroxysmal hemicrania and hemicrania continua have not been thoroughly studied leaving clinicians with few treatment options. gammaCore, which can be used to decrease the frequency, duration or intensity of PH and HC attacks, represents an important new treatment option for these patients.” Peter Goadsby, MD, PhD, DSc, president, American Headache Society, and professor of neurology, University of California–Los Angeles, said in a statement.¹

The noninvasive, hand-held medical therapy is applied at the neck and is designed as a portable, easy-to-use technology, according to electroCore. It can be self-administered by patients, as needed, and is placed on a patient’s neck over the vagus nerve, thus stimulating afferent fibers, leading to a reduction in patient.

READ MORE: Acute Migraine Treatment INP104 Approved

PH and HC, both rare forms of trigeminal autonomic cephalalgias (TAC), had no approved options prior to gammaCore. The most common type of TAC, cluster headache, can be treated with the device as well. In February, the FDA cleared the expansion of the nVNS system to include the preventive treatment of migraine in adolescents aged between 12 and 17 years, making it the only option acute and preventive for both adult and adolescent patients with migraine.²

The effectiveness of the device to treat both the acute and preventive side of migraine was further assessed and confirmed in a review published in May. The authors reviewed treatments and their performance in clinical studies and found only nVNS to be both useful for pain relief within 15 minutes in episodic cluster headache and for reducing the number of attacks per week in chronic cluster headache when used in addition to standard-of-care treatment.³

"gammaCore (nVNS) is the first treatment, drug or device, to be indicated for the treatment of paroxysmal hemicrania or hemicrania continua," Eric Liebler, senior vice president, Neurology, electroCore, said in a statement.¹ "The rare ability of nVNS to address several of the mechanistic pathways that contribute to the pain and symptoms of headache allows gammaCore to be used by patients as a treatment option for most forms of primary headache. We would like to thank the Division of Neuromodulation and Physical Medicine Devices and their colleagues at the FDA for their efforts to review and clear these new indications for gammaCore."

Since its original approval, the device has been looked at for several other neurological conditions, including patients with Parkinson disease (PD) and those under sleep deprivation stress. A recently conducted randomized, double-blind, sham-controlled crossover trial demonstrated nVNS’s ability to significantly improve key gait parameters, including walking speed, stance time, and step length in patients with PD as compared to sham.⁴

REFERENCES

1. electroCore announces 510(k) clearance of gammaCore non-invasive vagus nerve stimulation (nvNS) to treat paroxysmal hemicrania and hemicrania continua. News release. September 14, 2021. Accessed September 14, 2021. https://www.globenewswire.com/news-release/2021/09/14/2296594/0/en/electroCore-Announces-510-k-Clearance-of-gammaCore-Non-Invasive-Vagus-Nerve-Stimulation-nVNS-to-Treat-Paroxysmal-Hemicrania-and-Hemicrania-Continua.html

2. electroCore Announces 510(k) Clearance of gammaCore™ Non-Invasive Vagus Nerve Stimulation (nVNS) to Treat Adolescent Migraine. News release. February 16, 2021. Accessed September 14, 2021. globenewswire.com/fr/news-release/2021/02/16/2176061/0/en/electroCore-Announces-510-k-Clearance-of-gammaCore-Non-Invasive-Vagus-Nerve-Stimulation-nVNS-to-Treat-Adolescent-Migraine.html

3. Wei DY, Goadsby PJ. Cluster headache pathophysiology — insights from current and emerging treatments. Nat Rev Neurol. 2021:17:308-324. doi: 10.1038/s41582-021-00477-w

4. electroCore announces publication of study on non-invasive vagus nerve stimulation (nVNS) to improve clinical outcomes and molecular biomarkers in Parkinson disease patients. News release. electoCore. June 2, 2021. Accessed September 14, 2021. 2021. https://www.globenewswire.com/news-release/2021/06/02/2240288/0/en/electroCore-Announces-Publication-of-Study-on-Non-Invasive-Vagus-Nerve-Stimulation-nVNS-to-Improve-Clinical-Outcomes-and-Molecular-Biomarkers-in-Parkinson-s-Disease-Patients.html