National Institutes of Health Awards Grant for Pivotal Clinical Trial of gammaCore™ (nVNS) in Patients with Opioid Use Disorders
ROCKAWAY, N.J., April 26, 2023 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Emory University and the Georgia Institute of Technology a 3-year, $6.0 million grant through the NIH Helping to End Addiction Long Term (HEAL) Initiative to conduct a pivotal clinical trial of gammaCore (non-invasive vagus nerve stimulator; nVNS) for the treatment of opioid use disorder (OUD).
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 United States.2 Recurrent stress and exposure to triggers of traumatic memories in everyday life are a common precipitator of relapse in patients with OUD3,4 especially for women misusing prescription opioids.5
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 Georgia Tech School of Electrical and Computer Engineering, and co-principal investigator on the study added, “As a non-invasive, nonpharmacological therapy that poses minimal risk and is amenable to self-administration, nVNS represents a potentially valuable treatment for OUD.”
“We applaud the effort and leadership of Dr. Bremner, Dr. Inan, and their clinical and research teams at Emory University and the Georgia Institute of Technology, as well Dr. Volkow and her team at NIDA for their support of this grant,” said Peter Staats, MD, Chief Medical Officer at electroCore. “The personal, family and financial costs of opioid addiction represent an ongoing crisis in America and nVNS could offer a safe, effective and novel way to help patients through the critical initial phase of withdrawal thereby saving them pain and distress while also saving the healthcare system significant expense.”
About NIDA Grant
This work is supported by the NIH HEAL Initiative through the National Institute on Drug Abuse under award number UH3DA048502. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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 the United States and select overseas markets.
For more information, visit www.electrocore.com.
About gammaCore™
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 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, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua 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) and Medication Overuse Headache in adults.
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
Forward-Looking Statements
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 SEC, available at www.sec.gov.
Contact:
Rich Cockrell
CG Capital
404-736-3838
ecor@cg.capital
1 https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates
2 Prevention CfDCa. Drug Overdose Death Data. 2017;2018.
3 Wittenauer Welsh J, Knight JR, Hou SS-Y, Malowney M and Boyd JW. Association between substance
use diagnoses and psychiatric disorders in an adolescent and young adult clinic-based population. J
Adolesc Health. 2017;60:648-652.
4 Saal D, Dong Y, Bonci A and Malenka RC. Drugs of abuse and stress trigger a common synaptic
adaptation in dopamine neurons. Neuron. 2003;37:577-582.
5 Back SE, Lawson K, Singleton L and Brady KT. Characteristics and correlates of men and women with
prescription opioid dependence. Addict Behav. 2011;36:829-834.
6 Gazi AH, Harrison AB, Lambert TP, Obideen M, Alavi P, Murrah N, Shallenberger L, Driggers EG, Ortega RA, Washington BP, Walton KM, Welsh JW, Vaccarino V, Shah AJ, Tang YL, Gupta R, Back SE, Inan OT, Bremner JD. Transcutaneous cervical vagus nerve stimulation reduces behavioral and physiological manifestations of withdrawal in patients with opioid use disorder: A double-blind, randomized, sham-controlled pilot study. Brain Stimul. 2022 Sep-Oct;15(5):1206-1214. doi: 10.1016/j.brs.2022.08.017.
