National Institutes of Health Awards Grant for Pivotal Clinical Trial of gammaCore™ (nVNS) in Patients with Opioid Use Disorders
Opioid use disorder represents a national crisis with devastating consequences. Deaths from overdoses of opioids increased 8.5 fold from 1999 to 20201 making opioid overdose, including overdose involving prescription opioids and opioid-like synthetics like OxyContin and Percocet, as well as heroin and other illegal opioid substances like fentanyl, the leading cause of accidental death in
The double-blind, randomized, sham-controlled study is based on the successful completion and publication of a pilot study that showed that gammaCore nVNS reduced both the psychological and physiological symptoms of acute opioid withdrawal.6 The study to be funded by the grant will recruit approximately 100 patients with OUD. The primary efficacy endpoint of this study will be peak difference in the Subjective Opioid Withdrawal Score (SOWS) between nVNS and sham treatment on day 2 and 3 of the initial withdrawal period.
Dr. Douglas Bremner, Professor of Psychiatry and Radiology at Emory University School of Medicine and a principal investigator for the study commented, “We are pleased to be able to proceed with a pivotal trial to define the role of nVNS as a potential treatment for opioid use disorder. While treatments exist to help patients initiate and maintain opioid withdrawal programs, more effective options are needed.” Dr. Omer Inan, Professor and Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering in the
“We applaud the effort and leadership of Dr. Bremner, Dr. Inan, and their clinical and research teams at Emory University and the
About NIDA Grant
This work is supported by the NIH HEAL Initiative through the
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in
For more information, visit www.electrocore.com.
gammaCore™ (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 is 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 (nVNS) is FDA cleared in
gammaCore is contraindicated for patients 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 the neck
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Safety and efficacy of gammaCore have not been evaluated in the following patients:
- Adolescent patients with congenital cardiac issues
- 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 (less than 12 years)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
For more information, please visit gammaCore.com
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 regarding the results from investigator-initiated trials, anticipated results and timing of clinical trials being conducted with gammeCore (nVNS), electroCore's business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat the symptoms of acute withdrawal in patients with OUD, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "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 obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. The results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials, or commercial success. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the
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6 Gazi AH,