The U.S. Food and Drug Administration has cleared for sale in the U.S. a nerve stimulator for the treatment of rare cluster headaches that mostly affect men.
The device, called gammaCore, is made by electroCore of Basking Ridge, N.J. and stimulates the vagus nerve.
Cluster headaches have been referred to as “suicide headaches” due to their severity, according to electroCore. People who are heavy smokers or who have a family history of cluster headaches are at greater risk. The condition usually develops around the age of 30.
“Cluster headache is a rare, debilitating and difficult to treat disorder with few effective acute therapies,” said Dr. Stephen Silberstein, Director of the Headache Center at Jefferson University, Philadelphia, in a news release issued by electroCore. “The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache.”
An FDA news release on gammaCore was not posted online, but NBC News also reported the device’s approval. According to NBC News, cluster headaches affect less than 1 percent of people. Most have cluster headaches that come and go, aptly called episodic headaches.
Before the vagus nerve stimulator’s approval, previous treatments included a migraine headache drug delivered via an auto injector and inhaled oxygen.
gammaCore is a handheld device, NBC News reported. Similar devices are implanted.
In double-blind, placebo-controlled, randomized clinical trials (considered the gold standard in medical research), more than 34 percent of patients found relief using gammaCore.
“The U.S. release of gammaCore for the acute treatment of pain associated with episodic cluster headache in adult patients is a major milestone for electroCore, as it not only marks electroCore’s first FDA-released product, but also underscores our company vision to improve patient outcomes through technological advancements,” said Francis R. Amato, Chief Executive Officer of electroCore.
Vagus nerve stimulation already is used to control seizures and has been widely referred to as a “pacemaker for the brain.”
gammaCore already has been approved for use outside the U.S., including in the European Union. ElectroCore expects the product will be available in the U.S. by the fall.
Silberstein said gammaCore will be a game changer for cluster headache sufferers. “It is a way for patients to treat their symptoms as often as they need to use the device. It does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconveniently, costly, and high risk.”