electroCore Announces Non-Invasive Vagus Nerve Stimulation Clinical Update Publication in Cephalalgia
Paper supports use of nVNS as a front-line therapy for acute and preventative treatment of cluster headache and as an effective option for the treatment of migraine headache
BASKING RIDGE, N.J., July 28, 2020 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a paper, entitled, “Non-invasive vagus nerve stimulation for primary headache: a clinical update,”1 in Cephalalgia, the official journal of the International Headache Society (IHS).
The paper is a narrative review of recent scientific and clinical research into non-invasive vagus nerve stimulation (nVNS) for headache, including findings from mechanistic studies and their possible relationships to the clinical effects of nVNS. The review concludes that scientific and clinical studies support the emergence of nVNS as an effective, safe, well-tolerated, and practical treatment for primary headache disorders and supports the consideration of nVNS as: (1) a first-line treatment for both the acute and preventive treatment of cluster headache; (2) an effective option for acute treatment of migraine; and (3) a highly relevant, practical option for migraine preventive therapy.
“We are pleased with the scientific review and clinical recommendations made by the authors of this clinical update and hope that these recommendations, which we believe support the use of gammaCore™ (nVNS) in the treatment of both cluster and migraine headache, will help drive awareness of this novel technology by physicians and patients alike,” said Peter Staats, MD, Chief Medical Officer of electroCore.
Eric Liebler, Senior Vice President, Neurology at electroCore, and a co-author of the paper, commented, “The growing understanding of the first line role of nVNS for the treatment of cluster headache and its ability to be used acutely and preventively in migraine and cluster headache is a credit to the quality of the basic science and clinical trials that support these treatment recommendations.”
Dr. Stephen Silberstein, past President the American Headache Society, Director of the Jefferson Headache Center at the Thomas Jefferson University Medical Center, and the first author of the paper, commented, “Over the past several years the basic science and clinical evidence from studies completed across the United States and Europe have shown us not only the clinical benefit of nVNS but how and why it may be working in those patients. The interplay and overlap of the many ways nVNS affects the brain supports its ability to be used as a preventive and acute treatment for both cluster and migraine headache. Neuromodulation is a tool that we feel should be available to our cluster and migraine headache patients who need it.”
The paper is available via open access at: https://journals.sagepub.com/doi/full/10.1177/0333102420941864
Article funded by electroCore, Inc. See publication for disclosures.
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation (nVNS) therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua), Bronchoconstriction and Medication Overuse Headache in adults. In addition, the FDA has issued an Emergency Use Authorization (EUA) for use of gammaCore SapphireTM CV for acute use at home or in a healthcare setting to 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 as assessed by their healthcare provider. The FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
Patients should not use gammaCore if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device;
- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck; or
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Please refer to the gammaCore™ and gammaCore SapphireTM CV Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about the potential of nVNS to treat headache, electroCore’s business prospects and clinical and product development plans, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including potential human trials for the study of nVNS in COVID-19 patients in Spain, the U.S., or elsewhere, the business, operating or financial impact of such studies, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.
1 Silberstein, S. D., Yuan, H., Najib, U., Ailani, J., Morais, A. L. de, Mathew, P. G., … Diener, H.-C. (2020). Non-invasive vagus nerve stimulation for primary headache: A clinical update. Cephalalgia. https://doi.org/10.1177/0333102420941864