FDA OKs electroCore’s gammaCore for Preventive Treatment of Cluster Headaches

electroCore Inc., a commercial-stage bioelectronic medicine company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded label for gammaCore [non-invasive vagus nerve stimulator (nVNS)] therapy for adjunctive use for the preventive treatment of cluster headache in adult patients. This milestone marks the first and only product FDA cleared for the prevention of cluster headache. There are currently no FDA-approved pharmacologic treatments for the prevention of cluster headache.
 
“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as a ‘suicide headache,’” said Frank Amato, CEO at electroCore. “We are pleased that 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.”
 
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).
 
In this study, 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. The majority of the adverse events were mild and transient. The most common adverse events reported in five percent of patients or more in the gammaCore group were headache (8 percent), dizziness (6 percent) and neck pain (6 percent). None of the serious adverse events were considered device-related.
 
To prevent cluster headache, adult patients should self-administer two gammaCore treatments daily. Each treatment consists of three consecutive 2-minute stimulations. The first treatment should be applied within one hour of waking up and the second treatment should be applied at least 7-10 hours later.
 
gammaCore is available by prescription only and patients should speak with their doctor about whether gammaCore is right for them.