Vagal Stimulation Device Gets FDA Approval for Cluster Headaches
The device is applied to the neck and transmits a mild electrical stimulation to the vagus nerve through the skin.
The Food and Drug Administration (FDA) has approved the use of gammaCore (electroCore), the first handheld, non-invasive device to treat pain associated with episodic cluster headaches in adults. The device is applied to the neck and transmits a mild electrical stimulation to the vagus nerve through the skin.
The FDA release is based on results from 2 clinical trials, ACT1 and ACT2 (Non-Invasive Vagus Nerve Stimulation for the ACuteTreatment of Cluster Headache; ClinicalTrials.gov Identifiers: NCT01792817 and NCT01701245). Both trials were prospective, double-blind, placebo-controlled, randomized studies which evaluated the use of gammaCore vs placebo.
ACT1 had 85 participants with episodic cluster headaches. Efficacy of gammaCore was defined as the percentage of patients who reported mild to no pain 15 minutes after treatment initiation. Any use of rescue medication within 60 minutes was considered a treatment failure.
Results from ACT1 showed that 34.2% of patients experienced a reduction in pain compared to 10.6% of those in the placebo treatment group (P =.008). Results from the ACT2 study, which evaluated 182 cluster headache attacks in 27 patients, showed a significantly higher percentage of attacks were pain-free in the gammaCore group vs the placebo group: 47.5% vs 6.2% (P =.003).
Commenting on the FDA's release, Stephen Silberstein, MD, and lead research of the ACT1 study said, “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.”
GammaCore is already in use in the European Union. ElectroCore expects commercial availability of gammaCore in the U.S. sometime in the third quarter of 2017.
Cluster headaches are the least common type of headache disorder and occur in approximately 1 to 2 out of 1,000 individuals. They predominantly affect males and usually manifest by the age of 30.
For more information visit ElectroCore.com.