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 GrantThis 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 StatementsThis 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 CockrellCG
Capital404-736-3838ecor@cg.capital
1
https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates2
Prevention CfDCa. Drug Overdose Death Data. 2017;2018.3 Wittenauer
Welsh J, Knight JR, Hou SS-Y, Malowney M and Boyd JW. Association
between substanceuse diagnoses and psychiatric disorders in an
adolescent and young adult clinic-based population. JAdolesc
Health. 2017;60:648-652.4 Saal D, Dong Y, Bonci A and Malenka RC.
Drugs of abuse and stress trigger a common synapticadaptation 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 withprescription 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.
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