FDA releases electroCore's vagus nerve stimulator for episodic headaches
The US Food and Drug Administration (FDA) has released neuroscience and technology firm electroCore's non-invasive vagus nerve stimulator 'gammaCore', for acute treatment of pain caused by episodic cluster headaches in adults.
The hand-held medical device minimises pain by delivering a mild electrical stimulation to the vagus nerve, stimulating the afferent fibres of the nerve to modify pain signals.
Use of gammaCore eliminates the need for invasive implantation procedures, as well as the side-effects and dose limitations associated with standard treatments.
The device's portable, easy-to-use technology allows self-administration by the patients as often as required.
electroCore chief executive officer Francis Amato said: "The US release of gammaCore for the acute treatment of pain associated with episodic cluster headaches in adult patients is a major milestone for electroCore, as it not only marks its first FDA-released product, but also underscores our company vision to improve patient outcomes through technological advancements."
The release is based on the results from two prospective, double-blind, placebo-controlled, randomised trials in the non-invasive vagus nerve stimulation for the acute treatment of cluster headache (ACT) clinical trial programme.
The trials assessed the safety and efficacy of gammaCore and results indicated significant reduction of pain in 85 patients in ACT1 trial and 27 subjects in ACT2 trial.
gammaCore has secured CE Mark in the European Union (EU) for the acute and/or prophylactic treatment of primary headaches and medication overuse headaches in adults.
The device is also cleared, licensed, registered and/or approved in Australia, Canada, Colombia, Hong Kong, India, New Zealand, South Africa and Vietnam.
It is expected that gammaCore will be commercially available in the US in the third quarter of this year.
Image: gammaCore. Photo: courtesy of PRNewsfoto/electroCore LLC.