The Food and Drug Administration has granted 510(k) clearance to expand the approval of gammaCoreTM to include the treatment of paroxysmal hemicrania (PH) and hemicrania continua (HC) 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 14 patients with PH and 9 patients with HC.
The case report included 8 patients with paroxysmal HP who were intolerant to indomethacin. Results indicated that patients who received 2 consecutive doses 3 times a day ipsilateral to the pain had an average of 68.01% less headaches at 3 months (P =.012).
The clinical audit included 15 patients (HC: 9; PH: 6), of which 10 received noninvasive vagus nerve stimulation as the primary treatment (HC: 7; PH: 3). Among patients with HC, 7 (78%) reported experiencing a reduced severity of continuous pain, 2 reported a reduced frequency of exacerbations, and 1 reported reduced duration of exacerbation. Among patients with PH, 4 (67%) reported receiving benefits from the treatment, of which 1 patient became attack-free.
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.
Source: Medical Bag https://www.medicalbag.com/home/news/fda-clears-vns-device-for-paroxysmal-hemicrania-hemicrania-continua/