ElectroCore this week said it received FDA emergency use authorization for its gammaCore Sapphire CV to treat asthma exacerbations in known or suspected COVID-19 patients.
The gammaCore Sapphire CV is a non-invasive vagus nerve stimulation that can be used at home or in a healthcare setting to acutely treat adults with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow.
“Needless to say, we are very pleased to have received this EUA, and we intend to 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,” CEO Dan Goldberger said in a news release.
The EUA was issued after data from two prospective studies of VNS or nVNS to treat asthma was released by the company.
VNS for the treatment of acute asthma exacerbations showed FEV improved from baseline by a mean of 73% and mean VAS dyspnea score decreased from 8 (at baseline) to 1 90 minutes after acute percutaneous VNS treatment.
In another study, nVNS for the relief of acute bronchoconstriction due to asthma showed 93% of patients reported improvement in VAS dyspnea score and 86% had improvements in FEV 90 minutes after acute nVNS treatment.
“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,” chief medical officer Peter Staats said.