“Needless to say, we are very pleased to have received this EUA, and we intend work vigorously to make this novel therapy available to physicians treating known or suspected COVID 19 patients who are experiencing exacerbation of asthma-related breathing difficulty,” said Dan Goldberger, CEO of electroCore.
Peter Staats, MD, chief medical officer, went on to say, “Results from prior pilot studies that evaluated gammaCore for the acute treatment of asthma support our belief that nVNS may provide much needed relief to patients who are experiencing asthma-related breathing difficulty, which can be particularly debilitating in patients with COVID-19.”
JP Errico, electroCore Board member, co-founder and co-inventor of gammaCore, commented, “This FDA decision is an encouraging first step toward developing evidence that may provide a basis for electroCore to pursue expansion of nVNS into reactive airway disease (RAD), which was the first area of research for electroCore.”
The EUA is based on preliminary data from two prospective studies of use of VNS or nVNS to treat asthma:
Abbreviations: FEV1, forced expiratory volume in 1 second; nVNS, non-invasive vagus nerve stimulation; VAS, visual analog scale.
Staats.P, Giannakopoulos.G, Blake.J, Liebler.E, Levy.R. April 27, 2020. Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience, Neuromodulation: Technology at the Neural Interface
electroCore will provide additional details on the pricing and distribution of gammaCore CV under this EUA in the coming weeks.