gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) Reduces Symptoms of Acute Withdrawal in Patients with Opioid Use Disorder

ROCKAWAY, N.J., Sept. 07, 2022 (GLOBE NEWSWIRE) --  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer reviewed manuscript, 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 in the journal, Brain Stimulation. The study, conducted with the support of Emory and Georgia Tech University, was sponsored by a grant from the National Institute on Drug Addiction (NIDA), part of the National Institutes of Health (NIH), through NIH Helping to End Addiction Long-term^® Initiative, or NIH HEAL Initiative.

Substance use is an escalating crisis in the United States, with opioid-related drug overdose deaths rising above 100,000 in 2021.¹ The standard of care for treating opioid use disorder (OUD) is medication for opioid use disorder (MOUD), including opioid receptor agonists and antagonists. Yet, the barriers to care are high with only 11% of patients who have OUD receiving the MOUD they need.² Additionally, OUD relapse is common amongst patients. As many as 70% of patients with OUD return to use without medication and 46% of patients on methadone, an opioid agonist medication, will relapse.³ Treatment with the opioid antagonist naltrexone requires an extended period of detoxification before initiation, which can be associated with withdrawal symptoms. Relapse during this period may be associated with an even higher risk of relapse-related overdose and death.^4,5 New treatments are therefore necessary for managing withdrawal in the treatment of OUD.

This double-blind, randomized, sham-controlled study of 21 patients with OUD found that nVNS reduced both the psychological and physiological symptoms of acute opioid withdrawal. In particular, statistically significant reductions in opioid withdrawal symptoms (-1.9 ± 3.7 vs. 0.4 ± 1.0; p=0.047), distress (-17.5 ± 26.5 vs. 2.2 ± 5.9; p=0.004), and pain (-0.8 ± 2.4 vs. 0.9 ± 1.0; p=0.045) were observed over the course of a 2-hour protocol for the nVNS group, in comparison to the sham stimulation group. This was accompanied by a statistically significant decrease in heart rate during active nVNS compared to sham stimulation, across all stimulations (-5.5 ± 3.5 bpm vs. -1.4 ± 2.3 bpm; 0=0.035).

Dr. Douglas Bremner, Professor of Psychiatry and Radiology at Emory University School of Medicine and the primary investigator for the study commented, “Opioid Use Disorder is a crisis across the United States. Current treatments do not provide adequate options to help patients initiate and maintain opioid withdrawal programs.” Dr. Omer Inan, the Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering, Associate Professor of Electrical and Computer Engineering at Georgia Institute of Technology, and co-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 congratulate and thank Dr. Bremner, Dr. Inan, and their clinical and research teams at Emory University and Georgia Tech University, as well as the team at NIDA for their support of this study,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “Opioid addiction strikes individuals, families and society, and we look forward to continuing to partner with NIDA to confirm the potential of gammaCore (nVNS) as a treatment for OUD.”

The full publication is available at: https://www.brainstimjrnl.com/action/showPdf?pii=S1935-861X%2822%2900195-4

This work was supported by the National Institute on Drug Abuse and under award number 3UG3DA048502-01A1S2. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About the NIH HEAL Initiative
The Helping to End Addiction Long-term^® Initiative, or NIH HEAL Initiative^®, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company's current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

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 electroCore's business prospects, the results from investigator-initiated trials, 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 Acute Withdrawal in Patients with Opioid Use Disorder, 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. 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

¹Drug Overdose Deaths in the U.S. Top 100,000 Annually [Internet]. [cited 2022 Feb 25]. Available from: https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm

²https://www.samhsa.gov/data/sites/default/files/reports/rpt35325/NSDUHFFRPDFWHTMLFiles2020/2020NSDUHFFR1PDFW102121.pdf

³Mattick RP, Breen C, Kimber J, Davoli M. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane database Syst Rev. 2002 Apr 22;(4):CD002209.

⁴Krupitsky E, Nunes E V., Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet (London, England). 2011;377(9776):1506–13.

⁵Strang J, McCambridge J, Best D, Beswick T, Bearn J, Rees S, et al. Loss of tolerance and overdose mortality after inpatient opiate detoxification: follow up study. BMJ  Br Med J. 2003 May 3;326(7396):959.