The Food and Drug Administration has granted 510(k) clearance to expand the approval of gammaCoreTM to include the treatment of paroxysmal hemicrania and hemicrania continua in adults.
The hand-held non-invasive vagus nerve stimulation device is also indicated for the treatment and prevention of migraine in adults and adolescents, as well as for the treatment and prevention of cluster headache in adults. Paroxysmal hemicrania and hemicrania continua are both rare forms of trigeminal autonomic cephalalgias.
The label expansion was based on data from clinical audits and case reports that included a total of 14 patients with paroxysmal hemicrania and 19 patients with hemicrania continua. According to electroCore, treatment with gammaCore resulted in a decrease in the severity of persistent pain and/or reduction in the frequency, severity, and/or duration of exacerbations or attacks for nearly 80% of patients from each cohort.
As for safety, no serious adverse events were reported in the study. The portable device produces a low voltage electric signal that generates an electric field in the vicinity of the vagus nerve.
“gammaCore (nVNS) is the first treatment, drug or device, to be indicated for the treatment of paroxysmal hemicrania or hemicrania continua,” said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “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.”
The device is available through prescription only. Additional information on the prescribing process can be found here.
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. 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.
This article originally appeared on MPR