The Food and Drug Administration (FDA) has cleared gammaCore (electroCore), a non-invasive vagus nerve stimulator (nVNS) therapy, for adjunctive use to prevent cluster headache in adults.
Currently, there are no approved pharmacologic treatments for the prevention of cluster headache. gammaCore, a non-invasive, hand-held therapy, is indicated for self-administration twice daily; each treatment consists of 3 consecutive 2-minute stimulations. When applied at the neck, the device sends mild electrical stimulation through the skin which activates the vagus nerve resulting in the reduction of pain.
The FDA clearance was based on data from 2 studies. PREVA (PREVention and Acute treatment of chronic cluster headache), a prospective, open-label, controlled, randomized, clinical trial (N=93), showed the safety and efficacy of gammaCore as an adjunct therapy for the preventive treatment of cluster headache. Patients who received standard of care and gammaCore (SoC plus nVNS) during the randomized phase had a greater reduction from baseline in the number of cluster attacks per week vs patients who received standard of care alone (-5.9 vs -2.1; mean therapeutic gain -3.9 cluster attacks per week; P =.02). A site-adjusted model showed the mean therapeutic gain was -4.2 attacks per week (P =.02).
Also, more patients who received SoC plus nVNS had a 50% or greater reduction in weekly cluster attacks vs those who received SoC alone (40% vs 8.3%; P <.001). A 57% decrease in the frequency of abortive medication use among patients who received SoC plus nVNS was observed (P<.001) whereas patients who received SoC alone did not experience a substantial reduction in abortive medication use (P =.59).
gammaCore was safe and well tolerated in the study. The most common adverse events associated with therapy were headache, dizziness, and neck pain; the majority of adverse events were reported to be mild and transient.
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 cluster headache.
For more information visit electrocore.com.