gammaCore® Cluster Headache Treatment Device Gets FDA Approval

US-based ElectroCore announced that FDA has approved gammaCore®, the first non-invasive vagus nerve stimulation therapy applied at the neck for acute treatment of pain associated with episodic cluster headache in adult patients.

The device works on a simple principle – mild electrical pulse to the vagus-nerve through the epidermis (skin) results in reduction of pain.

The benefit of using the portable device is that it has reportedly no side effects or dose limitations, and can be used at any time by the patient in onset of symptoms.

gammaCore has been tested using 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 the medical device for the acute treatment of episodic cluster headache.

Both trials underwent prospective, double-blind, placebo-controlled, randomized studies for evaluating the use of gammaCore versus placebo.

Results from ACT1, from a pool of 85 patients with cluster headache, found that 34.2% of patients experienced a reduction in pain from episodic cluster headache.

The pain reportedly reduced 15 minutes after the treatment initiation compared to 10.6% in patients treated with placebo.

Results from ACT2 indicated that 47.5% of 27 patients experiencing 182 severe attacks went pain-free after 15 minutes with no use of rescue medication, compared to 6.2% in placebo users.

Cluster headache is a rare disorder that causes acute pain in only one side of the head.