electroCore Announces 510(k) Clearance of gammaCore™ Non-Invasive Vagus Nerve Stimulation (nVNS) to Treat Paroxysmal Hemicrania and Hemicrania Continua

About this update from Electrocore, Inc.

[{"type":"text","content":"ROCKAWAY, NJ, Sept. 14, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that on September 10, 2021 the company received Section 510(k) clearance from the United States Food and Drug Administration (FDA) of the company’s submission to expand the label of gammaCore nVNS to include the treatment of Paroxysmal Hemicrania (PH) and Hemicrania Continua (HC) in adults. PH and HC are both rare forms of trigeminal autonomic cephalalgias (TAC), that are typically debilitating and difficult to treat. The most common type of TAC is cluster headache. gammaCore is also indicated for both the acute and preventative treatment of cluster headache, where it is considered a first-line treatment option. The label expansion was based on data collected from multiple clinical audits and case series/case reports that included patients with PH or HC. These included a total of 14 patients with PH and 19 patients with HC. 79% of the patients experienced clinically meaningful benefits from gammaCore for each indication, including decreases in the severity of persistent pain and/or reductions in the frequency, severity, and/or duration of exacerbations or attacks. Many subjects reported more than one clinical benefit. There were no serious or unexpected adverse events reported. Professor Peter Goadsby MD, PhD, DSc, President of the American Headache Society and Professor of Neurology at the University of California, Los Angeles commented, “Paroxysmal hemicrania and hemicrania continua have not been thoroughly studied leaving clinicians with few treatment options. gammaCore, which can be used to decrease the frequency, duration or intensity of PH and HC attacks, represents an important new treatment option for these patients.” “gammaCore (nVNS) is the first treatment, drug or device, to be indicated for the treatment of paroxysmal hemicrania or hemicrania continua,” said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “The rare ability of nVNS to address several of the mechanistic pathways that contribute to the pain and symptoms of headache allows gammaCore to be used by patients as a treatment option for most forms of primary headache. We would like to thank the Division of Neuromodulation and Physical Medicine Devices and their colleagues at the FDA for thei...

More updates from Electrocore, Inc.