ElectroCore said today that it won expanded FDA 510(k) clearance for its GammaCore non-invasive vagus nerve stimulation therapy, now cleared for adjunctive use for the preventive treatment of cluster headaches in adult patients.
The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve.
The expanded approval was supported by results from two studies which demonstrated the safety and efficacy of the system in preventing the treatment of cluster headaches, ElectroCore said, including data from its pivotal Preva study and a real-world retrospective study.
Results from the Preva study indicated that patients who received the standard of care and treatment and treatment with the GammaCore had a greater reduction in the number of cluster attacks per week from baseline than those who only received the standard of care. Patients treated with the GammaCore device experienced a total of 3.9 fewer attacks per week, ElectroCore said.
Data also indicated that 40% of patients who received GammaCore treatment alongside the standard of care had a 50% or greater reduction in weekly cluster attacks, versus only 8.3% of patients who received the standard of care, ElectroCore said. Investigators also noted a 57% decrease in the frequency of abortive medication for GammaCore patients.
The incidence of adverse events was noted as similar between both treatment and control cohorts, with most reported adverse events noted as mild or transient. The most common adverse events reported in the GammaCore group were headache, dizziness and neck pain at 8%, 8% and 6%, respectively. No serious adverse events were considered device-related, the company said.
“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. 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,” CEO Frank Amato said in a press release.
In August, ElectroCore said that it inked a collaborative research deal with Massachusetts General Hospital exploring the use of ElectroCore’s non-invasive vagus nerve stimulation tech in targeted treatments for neuroinflammation.