electroCore, based out of Basking Ridge, New Jersey, received the first FDA clearance for a product to prevent cluster headache. The gammaCore non-invasive vagus nerve stimulation (nVNS) system was previously cleared for treating pain that has already kicked in, that is related to migraines and episodic cluster headaches. The new clearance means that doctors can prescribe it for prevention as well.
The latest version of the device, called gammaCore Sapphire, has a couple electrodes that are placed on the neck over the location of the vagus nerve. The device sends electric current through the skin to the nerve, and toward the brain, disrupting processes that cause certain types of pain.
The device, about the size of a smartphone, is small enough to be carried around, and therapy can be administered at will and as needed. There doesn’t seem to be any known serious side effects from this kind of therapy, so it seems to be safe for repeated and regular use, as long as it’s used by adults.
Here’s some data from the studies that led to this latest clearance, according to electroCore:
This clearance was supported 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 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 cluster headache.
In the PREVA study, intention-to-treat (ITT) patients who received the standard of care and gammaCore (SoC plus nVNS, n=45; control, n=48) during the randomized phase had a greater reduction from the baseline (−5.9) in the number of cluster attacks per week than those receiving standard of care (−2.1), for a mean therapeutic gain of 3.9 fewer cluster attacks per week (P=0.02). In the site-adjusted model, the mean therapeutic gain was 4.2 fewer attacks per week (P=0.02).
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 (P<0.001).
In addition, there was a 57 percent decrease in the frequency of abortive medication use among patients who received gammaCore plus standard of care (P<0.001), while patients who received standard of care alone did not experience a substantial reduction in abortive medication use (P=0.59).
Here’s a video showing how to use the gammaCore Sapphire, the latest version of electroCore’s nVNS therapy:
Flashbacks: Vagus Nerve Stimulation for the Masses: Interview with electroCore CEO J.P. Errico…; gammaCore Sapphire Helps Control Migraines and Cluster Headaches: Now Available in U.S…; gammaCore Personal Non-Invasive VNS Cleared for Episodic Cluster Headaches…
Product page: gammaCore…