FDA Releases Non-Invasive VNS Therapy for Pain Associated with Episodic Cluster Headache

Tuesday, April 18, 2017 | FDA Approval/Clearance , Headache & Pain


The FDA has released the use of gammaCore, a non-invasive vagus nerve stimulator for the acute treatment of pain associated with episodic cluster headache in adult patients. gammaCore transmits a mild electrical stimulation to the vagus nerve through the skin, resulting in a reduction of pain.

The decision was based on subgroup analyses from two trials in the ACT (Non–Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache) clinical trial program evaluating the safety and efficacy of gammaCore for the acute treatment of episodic cluster headache. Results from ACT1 found that 34.2 percent of patients experienced a reduction in pain from episodic cluster headache, as compared to 10.6 percent in patients treated with placebo. In the ACT2 study, 47.5 percent of cluster headache attacks were pain-free in patients treated with gammaCore, as compared to only 6.2 percent in the placebo group. In both trials, gammaCore was found to be safe and well-tolerated, with the majority of adverse events being mild and transient and occurring during the time of active treatment.

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