The horizon for FDA emergency COVID-19 authorizations continues to expand beyond first-line respiratory and airway-focused devices such as ventilators, as more of the industry finds ways to help treat the disease.
The bioelectric therapy developer electroCore received an agency green light for its vagus nerve stimulation device, aimed at reducing exacerbations in people potentially affected by the novel coronavirus and have difficulty breathing due to asthma.
The company’s hand-held gammaCore Sapphire CV, for use at home or in a hospital, will be made available to patients that cannot tolerate approved drug therapies or have not seen sufficient relief in their symptoms. The device is pressed against the neck to stimulate the large nerve connecting the brain with the lungs, heart and digestive system.
“This FDA decision is an encouraging first step toward developing evidence that may provide a basis for electroCore to pursue expansion of [non-invasive vagus nerve stimulation] into reactive airway disease, which was the first area of research for electroCore,” said co-founder JP Errico, who helped invent the gammaCore system, which previously received FDA clearances aimed at relieving migraines and cluster headaches.
According to electroCore, the new emergency authorization was based in part on preliminary data from a prospective study of 30 people, who had acute constrictions of their airways due to asthma. An hour-and-a-half after the treatment, 93% of patients reported improvements in breathing and 86% saw increases in lung capacity.
“Results from prior pilot studies that evaluated gammaCore for the acute treatment of asthma support our belief that [non-invasive vagus nerve stimulation] may provide much-needed relief to patients who are experiencing asthma-related breathing difficulty, which can be particularly debilitating in patients with COVID-19,” said electroCore’s chief medical officer, Peter Staats.
The company said it plans to announce additional details on the system’s pricing and distribution under the emergency authorization in the coming weeks.