ARTICLE SUMMARY:
The neuromodulation company has leveraged its original R&D into a treatment for COVID-19.
electroCore Inc.’s noninvasive vagus nerve stimulation device is the only device cleared for the prevention and treatment of cluster headache, and it’s also cleared for the prevention and treatment of migraine. But the company’s first plan for its technology was to address inflammation and the airway reactivity and bronchoconstriction that occur during asthma as well as anaphylaxis. The company has parlayed that original research into an FDA Emergency Use Authorization for use of its device in COVID-19 patients.
On July 13, 2020 the FDA issued an EUA covering the use of electroCore’s noninvasive vagus nerve stimulation device, gammaCore Sapphire CV for the treatment of asthma exacerbation associated with COVID-19. In the hospital, such treatment has the potential to keep patients off of ventilators, or it might keep patients out of the hospital in the first place.
The EUA, which was granted based on data from two small, prospective, multicenter, open-label studies, specifically covers patients diagnosed with or suspected of having COVID-19 who are experiencing asthma-related dyspnea and reduced airflow. A small study that recently appeared in the journal Neuromodulation also suggested the clinical benefits of the therapy, which allowed one patient to be discharged sooner and expedite recovery at home, where he was able to discontinue the use of opioid and cough suppressant medications. A second patient experienced immediate relief from bronchoconstriction and an improved ability to clear his lungs.
Returning to its roots, electroCore is making use of the ability of the vagus nerve to modulate pathologic inflammation by blocking activation of the cholinergic anti-inflammatory pathway, which is implicated in a variety of inflammatory conditions including asthma, septic shock, stroke, and rheumatoid arthritis. While cleared in the US for migraine and cluster headaches, in the EU gammaCore is cleared for the treatment and prevention of symptoms related to reactive airway disease, among other applications.
gammaCore is well suited for pandemic applications; it is easy for patients to use, and can be prescribed and delivered to them without an in-person visit. As a therapy, it is not prone to spreading the virus, as are nebulizers and steroids administered through inhalers.
Two investigator-initiated trials studying the COVID-19-related applications of gammaCore are currently enrolling. Enrollment has been going slower than desired, but over time, these investigator-initiated trials should clarify the potential of gammaCore in this additional application.
Excerpted from “electroCore: A Surprising COVID Angle,” MedTech Strategist, October 21, 2020.
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