FDA clears VNS Therapy for prevention of Cluster Headache

The U.S Food and Drug Administration (FDA) issued clearance certification to gammaCore, a non-invasive vagus nerve stimulator (nVNS) therapy, for adjunctive use to prevent a cluster headache in adults, announced electroCore, Inc,a commercial-stage bioelectronic medicine company.

The GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve. It is indicated for self-administration twice daily and each treatment consists of 3 consecutive 2-minute stimulations.

Currently, there are no approved pharmacologic treatments for the prevention of a cluster headache.

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According to Frank Amato, Chief Executive Officer at electroCore, the cluster headache patients now have an FDA-cleared option and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments.

GammaCore device got clearance backed up by results from two studies, including from the PREVA (PREVention and Acute treatment of chronic cluster headache) pivotal study, a prospective, open-label, controlled, randomized clinical trial that demonstrated the safety and effectiveness of gammaCore as an adjunctive therapy for the preventive treatment of a cluster headache. The second study reviewed by the FDA was a real-world retrospective study examining the daily clinical use of gammaCore preventively and acutely for the treatment of a cluster headache.

In the PREVA study, forty-five intention-to-treat (ITT) patients received the standard of care and gammaCore (SoC plus nVNS, n=45) who during the randomized phase had a greater reduction from the baseline in the number of cluster attacks per week than those receiving standard of care. Furthermore, 40 percent of patients who received gammaCore in addition to standard of care experienced a 50 percent or greater reduction in weekly cluster attacks, compared to 8.3 percent of patients who received standard of care alone.

In addition, there was a 57 percent decrease in the frequency of abortive medication use among patients who received gammaCore plus standard of care while patients who received standard of care alone did not experience a substantial reduction in abortive medication use.

GammaCore was found to be safe and well tolerated. The incidence of adverse events was similar between patients using gammaCore plus standard of care compared to standard of care alone.

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The most common adverse events reported in five percent of patients or more in the gammaCore group were a headache (8%), dizziness (6%) and neck pain (6%). None of the serious adverse events were considered device-related.

The FDA also reviewed data from a real-world retrospective study which evaluated the daily clinical use of gammaCore preventively and acutely for the treatment of a cluster headache.

A cluster headache is a series of relatively short but extremely painful headaches that has been described by patients and physicians as one of the most painful conditions in medicine.