electroCore Receives FDA Clearance for gammaCore

electroCore (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today 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.

As quoted in the press release:

“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, Chief Executive Officer at electroCore. “We are pleased that cluster headache patients now have a 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.

Click here to read the full press release.