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electroCore Announces FDA Emergency Use Authorization for use of gammaCore Sapphire™ CV for the Acute Treatment of Asthma Exacerbations in Known or Suspected COVID-19 Patients
Intended use allows gammaCore Sapphire CV use at home or in a healthcare setting BASKING RIDGE, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- electroCore, Inc.
About this update from Electrocore, Inc.
[{"type":"text","content":"Intended use allows gammaCore Sapphire CV use at home or in a healthcare setting\nBASKING RIDGE, N.J., July 13, 2020 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today 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.\n “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. 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: StudyDesignNFindingsVNS for the treatment of acute asthma exacerbationsProspective, multicenter, open-label study490 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 1nVNS for the relief of acute bronchoconstriction due to asthmaProspective, multicenter, open-label study3090 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...