ElectroCore announced that the expanded indication, noting that gammaCore is now the only acute and preventive option approved for both adult and adolescent migraine.
The FDA has cleared the expansion of the gammaCore noninvasive vagus nerve stimulation (nVNS) device’s label to include the preventive treatment of migraine in adolescent patients aged between 12 and 17 years, according to its manufacturer electroCore.1
Eric Liebler, senior vice president of neurology, electroCore, noted in a statement that this marks gammaCore as the only option acute and preventive for both adult and adolescent patients with migraine, which he noted is “represents a unique treatment” for those seeking to avoid the use of prescription pharmaceutical agents.
“Migraine is a very common disease in adolescents that can affect them at home, school, and socially. gammaCore, which can be used acutely to treat migraine attacks, or when used daily can decrease the number of attacks, is an exciting treatment that I look forward to offering to my adolescent patients,” Andrew Hershey, MD, PhD, FAHS, Endowed Chair, and director of neurology, Cincinnati Children’s Medical Center, and professor of pediatrics and neurology, University of Cincinnati College of Medicine, said in a statement.
Previously reported randomized controlled trial data offered the basis for this label expansion, as well as a small study in adolescents (n = 9) with migraine with aura, in which 46.8% (n = 22) of 47 treated attacks were successfully resolved without the use of any acute rescue medication. There were no device-related adverse events (AEs) reported in the preliminary study.2
This expanded indication gives the device the OK for a number of variations of primary headache, including both acute and preventive treatment in adults and this new, younger population, as well as both uses for cluster headache in adults.
In August 2020, a clinical update suggested that the combination of the safety and tolerability of the gammaCore device support its use in cluster headache, leaning on identified clinical and mechanistic evidence. It used clinical trial evidence from 2 randomized, double-blind trials—ACT1 (NCT01792817) and ACT2 (NCT01958125)—a meta-analysis, and real-world assessment to assess the device’s efficacy and safety in cluster headache.
Most notably, it identified 4 core areas providing mechanistic explanations for the device’s efficacy: Effects on autonomic nervous system functions; inhibition of cortical spreading depression; neurotransmitter regulation; and nociceptive modulation.3
Additionally, that literature review implied that nVNS is also an effective option for acute migraine treatment and a practical option for migraine prevention. The review was conducted by Stephen D. Silberstein, MD, professor of neurology, and director, Jefferson Headache Center, Thomas Jefferson University, and colleagues, and included the findings from mechanistic studies and their possible relationships to the clinical effects of nVNS, as well as safety data, representing the largest dataset a neuromodulation device.
Similar to the cluster headache literature, in migraine, the PRESTO (NCT02686034), EVENT (NCT01667250), and PREMIUM (NCT00355056) studies were positive for gammaCore. With regard to the overall safety profile, there were serious treatment-related AEs reported in any of the controlled clinical trials of nVNS for cluster headache (including the PREVA trial [NCT01701245]) or migraine.
As of now, the safety and efficacy of the device have yet to be established in those with carotid atherosclerosis, who have undergone cervical vagotomy, women who are pregnant, or those with clinically significant hypertension, hypotension, bradycardia, or tachycardia. As well, it not recommended to be used for those individuals with an active implantable medical device, metallic device (stent, bone plate, or bone screw) implanted at or near the neck, or for simultaneous use with another device or any portable electronic device.