FDA gives expanded approval for GammaCore for preventive treatment of cluster headache.- ElectroCore.

ElectroCore announced that it received 510(k) clearance from the 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.

This clearance was supported by results from two studies, including from the PREVA 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.>