electroCore Receives FDA Emergency Use Authorization for use of gammaCore Sapphire CV For COVID-19 Treatment

FDA Emergency Use Authorization gammaCore Sapphire COVID19
Image: gammaCore

One of the symptoms of COVID-19 is respiratory problems, and people with asthma are badly affected by the disease as it can make breathing even more difficult. Now, electroCore, a commercial-stage bioelectronic medicine company, announced that the FDA has issued an Emergency Use Authorization (EUA) authorizing the use of gammaCore Sapphire™ CV non-invasive vagus nerve stimulation (nVNS) at home or in a healthcare setting to acutely treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief, reports GlobeNewsWire.

“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, Chief Executive Officer of electroCore.

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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.”

gammaCore Saphire
Image: gammaCore

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.”

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electroCore will provide additional details on the pricing and distribution of gammaCore CV under this EUA in the coming weeks.

The EUA is based on preliminary data from two prospective studies of use of VNS or nVNS to treat asthma:

Study                    Design                  N                          Findings

VNS for the treatment of acute asthma exacerbations

nVNS for the relief of acute bronchoconstriction due to asthma

Prospective, multicenter, open-label study 4 90 minutes after acute percutaneous VNS treatment, FEV1 improved from baseline by a mean of 73%, and mean VAS dyspnea score decreased from 8 (at baseline) to 1
Prospective, multicenter, open-label study 30 90 minutes after acute nVNS treatment, 93% of patients reported improvement in VAS dyspnea score, and 86% had improvements in FEV1

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.

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Cathy Russey () is Online Editor at WT | Wearable Technologies and specialized in writing about the latest medical wearables and enabling technologies on the market. Cathy can be contacted at info(at)wearable-technologies.com.