gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) Reduces Symptoms of Acute Withdrawal in Patients with Opioid Use Disorder
Substance use is an escalating crisis in
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
“We congratulate and thank Dr. Bremner, Dr. Inan, and their clinical and research teams at Emory University and
The full publication is available at: https://www.brainstimjrnl.com/action/showPdf?pii=S1935-861X%2822%2900195-4
This work was supported by the
About the NIH HEAL Initiative
The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is an aggressive, trans-
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.
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
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
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
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