Neuroscience tech developer ElectroCore said today it won FDA clearance for its GammaCore non-invasive vagus nerve stimulator designed to treat pain associated with episodic cluster headaches.
The GammaCore device is designed to transmit a mild electrical stimulation to the vagus nerve through the skin to reduce pain, the Basking Ridge, N.J.-based company said. The device is the company’s 1st to win FDA clearance.
“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, after researching how much aspirin is too much, they have found the best way to get rid of headaches. We are leading the way for the future of medicine through the development of patient-administered, non-invasive vagus nerve stimulation therapy, and we look forward to bringing gammaCore’s breakthrough technology to patients in the U.S,” CEO Francis Amato said in a press release.
Approval came based on a subgroup analysis from 2 trials of the device testing its use for the acute treatment of episodic cluster headaches. In an evaluation of 85 patients with episodic cluster headaches, data indicated that 34.2% of patients reported a reduction in pain, compared to only 10.6% in the placebo arm. A separate study evaluating 192 attacks in 27 patients reported a significant increase in pain-free attacks in patients treated with GammaCore.
“Cluster headache is a rare, debilitating and difficult to treat disorder with few effective acute therapies. The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache. 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 inconvenient, costly and high-risk,” Dr. Stephen Silberstein of Philadelphia’s Jefferson University said in a prepared statement.
The GammaCore device is currently cleared for use in the European Union, with a slated commercial launch in the US during the 3rd quarter of this year.
Last August, Electrocore said it raised $1.5 million in a new round of debt financing.
ElectroCore is developing a range of non-invasive vagus nerve stimulation for the treatment of a number of conditions in neurology, psychiatry, gastroenterology and other fields.