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The therapy will also be available for individuals with asthma and suspected COVID-19 infection.
The FDA has issued an Emergency Use Authorization (EUA) to electroCore, Inc for its gammaCore Sapphire CV non-invasive vagus nerve stimulation (nVNS), a therapy for patients with confirmed or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the novel coronavirus disease 2019 (COVID-19), who are experiencing flares in asthma-related dyspnea and reduced airflow, where medications fail to assuage symptoms.1
“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,” Peter Staats, MD, chief medical officer, electroCore, said in a statement.1
The gammaCore nVNS is the first non-invasive, hand-held medical therapy, which is used by applying it to either side of patient’s neck, that alleviates pain by way of mild electrical stimulation to the vagus nerve’s afferent fibers. The EUA will allow the device to be used at home and in health care settings, and can be self-administered through an easy-to-use and portable design.1
FDA authorization of the device stemmed from 2 prospective cases reporting preliminary data that support the use of VNS or nVNS therapies for asthma. Authors of the studies wrote that respiratory symptoms associated with COVID-19 may be due to a hyperimmune reaction called a cytokine storm. Since vagus nerve stimulation has shown to block the production of cytokines, the authors assessed whether nVNS would provide clinical benefits in patients suffering from respiratory symptoms mirroring those seen in COVID-19 patients.2
The cases reported clinically significant benefits from the therapy; in the first case, the patient incorporated nVNS therapy at home following his discharge from the hospital, and subsequently no longer needed opioid and cough suppressant medications. In the second case, data from the patient reported immediate and consistent relief from chest tightness and shortness of breath.2
In addition to these cases, the authors also cited numerous respiratory clinical trials that incorporated nVNS treatment and produced clinical benefit, including randomized controlled trials (RCTs).2
Study investigators also discussed the possibility of nVNS to curb transmission of COVID-19 as it has shown to decrease cough, a primary entry mechanism for the virus when individuals are without a mask.
As for further investigation, the study authors wrote that RCTs for evaluating nVNS treatment in COVID-19 patients are underway in the United States and Europe.2
“Previous findings suggest that the clinical benefits from VNS and nVNS are driven by mechanisms of action relevant to COVID‐19. The robust established safety and tolerability profile of nVNS strengthens the case for the additional investigation and use of nVNS to fight the COVID‐19 pandemic,” the authors concluded.