gammaCore Nerve Stimilator Expanded for Headaches

FDA has cleared an electroCore 510(k) for an expanded label for gammaCore vagus nerve stimulator therapy for adjunctive use for preventing cluster headaches in adult patients. The clearance was supported by data from two studies, including PREVA (PREVention and Acute treatment of chronic cluster headache), a prospective, open-label, controlled, randomized clinical trial. In the study, intention-to-treat patients who received the standard of care and gammaCore during the randomized phase had a greater reduction from baseline in the number of cluster attacks per week than those receiving standard of care — for a mean therapeutic gain of 3.9 fewer cluster attacks per week, the company says. Additionally, it showed that 40% of patients who received gammaCore in addition to standard of care experienced a 50% or greater reduction in weekly cluster attacks, compared to 8.3% of patients who received standard of care alone.