electroCore Announces Selection of gammaCore for National Institute on Drug Abuse (NIDA)-Sponsored Study in Opioid Use Disorders
Randomized controlled study run by Dr. Douglas Bremner at Emory University in collaboration with the Georgia Institute of Technology and the City University of New York
BASKING RIDGE, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that its gammaCore non-invasive vagus nerve stimulator (nVNS) has been selected for evaluation in a randomized controlled study for the treatment of opioid use disorders. The study is being run by Dr. Douglas Bremner at Emory University in collaboration with the Georgia Institute of Technology and the City University of New York and is supported by the National Institute on Drug Abuse (NCT04556552).
The study will enroll 40 subjects, in two separate study groups of 20 subjects each. Each study group will randomize 10 subjects to be treated with nVNS and 10 with sham stimulation. The study will assess the ability of nVNS to decrease opioid cravings in subjects with a history of opioid use disorder who are stable on medication, as well as examine the possible mechanisms that might facilitate this clinical effect.
Dr. Douglas Bremner, Professor of Psychiatry and Behavioral Sciences and Radiology at the Emory University School of Medicine, staff physician at the Atlanta Veterans Clinic General Mental Health Unit at the Atlanta VA Medical Center and primary investigator of the study, commented: “Opioid use disorders (OUDs) are highly prevalent and potentially lethal conditions that are often linked to trauma and post-traumatic stress disorder. These conditions are of particular concern to the VA and limited treatment options currently exist. The use of nVNS during the opioid withdrawal period represents a potential new innovation versus current treatments that rely on medication and counseling, widely acknowledged to have limitations during this critical period. Novel treatments are needed that address the underlying neurobiology of OUDs involving the sympathetic nervous system, inflammatory responses, and brain areas and systems mediating craving and addiction. nVNS has previously been shown to be effective in treating a number of conditions, including most forms of primary headache, depression and epilepsy, and has also been shown to affect the underlying neurobiology of OUDs.”
Peter Staats, MD, MBA, Chief Medical Officer of electroCore and President-elect of the World Institute of Pain, stated: “Addiction is a significant health crisis in the United States. Data suggests that nVNS may play a meaningful role in the treatment of addiction by ameliorating the devastating cravings associated with opioids and opioid withdrawal. With the introduction of our effective, safe and practical handheld treatment in the form of gammaCore (nVNS), we are now in a position to fully investigate the clinical potential of nVNS in this important area. This has not been possible with vagus nerve stimulation generated through surgically implanted devices. The Health and Human Services’ Best Practices for Pain Management Task Force already highlights nVNS as an alternative to opioids for patients suffering from cluster and migraine headache, and Dr. Bremner’s work suggests that nVNS may have a much broader role in the treatment of patients with addiction and withdrawal as well. We all look forward to results of this important study.”
The study will enroll subjects with confirmed OUDs based on DSM-5 criteria from the greater Atlanta metropolitan region. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), over 100,000 people in the Atlanta area engage in non-medical use of prescription pain relievers, and almost half of them are estimated to have an opioid use disorder. The study will recruit from treatment programs in the greater Atlanta metropolitan region, including the residential, detoxification and other treatment programs of the DeKalb Community Service Board, which, with over 30,000 patient visits per year, represents the largest treatment program for OUDs in one of two counties in greater Atlanta.
For more information on the Health and Human Services’ Pain Management Best Practices Inter-Agency Task Force Report please visit: https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf
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 therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy 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) and Medication Overuse Headache in adults.
- 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
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
In the US, 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.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
gammaCore Sapphire™ CV has received Emergency Use Authorization (EUA) from the FDA 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, by using non-invasive Vagus Nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
gammaCore Sapphire CV has neither been cleared nor approved 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, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic
gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.
Please refer to gammaCore Sapphire CV (nVNS) Instructions for Use for Use for all of the important warnings and precautions before using or prescribing gammaCore Sapphire CV (nVNS).
This press release and other written and oral statements made by representatives of electroCore 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 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; the business, operating or financial impact of such studies; the potential of nVNS generally and gammaCore in particular to treat opioid use disorders 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™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, 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.