FDA Approves Vagus Stimulation Device for Cluster Headache
The thumbs-up decision for the gammaCore (electroCore LLC) marks the agency's first release of a hand-held, neck-applied device for this indication.
The portable device lets patients self-administer mild electrical stimulation to the vagus nerve whenever they need relief from the debilitating symptoms of cluster headache — a condition that affects about 350,000 individuals in the United States, according to the manufacturer.
The FDA release was based on the prospective, placebo-controlled ACT1 and ACT2 trials. In ACT1, which included 85 participants with episodic cluster headache, 34% of those in the vagus nerve stimulation group reported pain reduction after treatment vs 11% of the placebo group.
ACT2 assessed 27 patients, with 182 total attacks. Results showed 47.5% of those treated with the active device were pain-free 15 minutes later vs 6.2% of those receiving placebo.
Treatment-related adverse events in both trials were considered to be mild and transient.
"The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache," Stephen Silberstein, MD, director of the Headache Center at Jefferson University, Philadelphia, Pennsylvania, said in the company statement.
The device "does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconvenient, costly, and high-risk," added Dr Silberstein.
Francis R. Amato, chief executive officer of electroCore, reported that this is the company's first product to be released by the FDA and that "we look forward to bringing gammaCore's breakthrough technology to patients in the US."
The company notes that the device is not indicated for patients with an active implantable medical device, such as a pacemaker or hearing aid implant; those with carotid atherosclerosis or who have had a cervical vagotomy; those with hypertension, hypotension, bradycardia, or tachycardia; or pregnant women or pediatric patients.
It should also not be used by those with a stent, bone plate, or bone screw implanted near the neck or used with another device at the same time, such as a transcutaneous electrical neurostimulation unit, muscle stimulation, or any portable electronic device, including mobile phones.
The stimulator is currently CE-marked in the European Union for treating adults with primary headache and medication overuse headache. It has also been released/cleared and/or approved in Canada, Australia, New Zealand, Hong Kong, India, South Africa, Vietnam, and Colombia.
FDA Approves Vagus Stimulation Device for Cluster Headache. Medscape. April 19, 2017.
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