electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic
medicine and wellness company, today announced top line data from
an abstract being presented as an oral podium presentation at the
2023 American College of Gastroenterology Annual Meeting held in
Vancouver, Canada from October 23-25, 2023 regarding the potential
for nVNS to decrease the use of acute rescue medications for
exacerbations of nausea due to Gastroparesis (GP) or Functional
Dyspepsia (FD).
Many gastrointestinal disorders can cause nausea and vomiting,
of which the most well-known is gastroparesis, a digestive disorder
in which the stomach empties slowly.1 The symptoms of
gastroparesis can range from mild to severe, requiring prolonged
hospitalizations and interventions, and causing life-threatening
complications which can significantly affect the quality of life in
affected individuals. It is estimated that close to 6 million
Americans suffer from gastroparesis which is more common in women
than men.2 The economic impact of gastroparesis can be
substantial, with studies reporting 11% of patients disabled due to
their gastroparesis symptoms, while another 28.5% reported a loss
of yearly income.3
Nausea without slow gastric emptying may be even more common and
has been referred to by many names, including chronic unexplained
nausea and vomiting (CUNV), gastroparesis-like syndrome (GLS),
functional vomiting, and vomiting of unexplained etiology (VUE).
Many of these patients can be classified as having functional
dyspepsia (FD) which is a disorder that may affect 10% of the US
population.4
Non-Invasive Vagal Nerve Stimulation (nVNS) Reduces
Nausea Rescue Medication in Patients with Gastroparesis and Related
Disorders, with Additional Benefits on Multiple Other Associated
Symptoms
This pilot study (n=41) included patients ≥15 years of age with
ongoing GP or FD symptoms for a period of ≥3 months. The primary
endpoint was reducing the use of antinausea medications by using
nVNS as the primary rescue treatment for nausea exacerbations.
Exploratory endpoints included changes in GI, autonomic, and
psychological symptoms via standardized questionnaires. The study
showed nVNS reduced the use of rescue pills per day by more than
50% (p=0.0007; Figure 1). This benefit was maintained throughout
each 4-week treatment period of the crossover study as well as
during the two, two-week, washout periods. Exploratory endpoints
revealed robust improvements in abdominal pain, reflux,
indigestion, and constipation. Depression levels, as measured by
the Beck Index, improved, and Migraine scores improved with the
subjects using fewer headache/migraine pills per day during the
study. No serious device-related adverse effects were reported.
Peter Staats, MD, Chief Medical Officer for electroCore,
commented, “We congratulate all the investigators and patients that
supported this research into the role of nVNS as a novel,
non-pharmacologic treatment for patients suffering from
gastroparesis. The significant decrease in the use of rescue
medications, combined with the many benefits seen in the
accompanying symptoms that often plague patients with gastroparesis
suggest a new and important role for nVNS.”
FIGURE 1
Primary Endpoint (n=35): Average number of nausea pills. Overall
significance (Type 3 F test): p=0.0007
Presentation Details:Date:
Wednesday October 25, 2023, 9:00 AM - 9:10
AMSession: Plenary Session 4B - IBD / Obesity /
StomachPresentation 68: Non-Invasive Vagal Nerve
Stimulation Reduces Nausea Rescue Medication in Patients With
Gastroparesis and Related Disorders, With Additional Benefits on
Multiple Other Associated Symptom
Authors: Guillermo Barahona5, Luisa Villatoro5,
Glenn Treisman6, Megan McKnight6, Robert Burns6, Candace K.
McClure7, Eric Liebler8, Pankaj Jay Pasricha5
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.
Forward-Looking StatementsThis 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 including potential commercial
applications of gammaCore and nVNS to decrease the use of acute
rescue medications for exacerbations of nausea due to Gastroparesis
and Functional Dyspepsia; its pipeline or potential markets for its
technologies; the timing, outcome and impact of regulatory,
clinical and commercial developments; the issuance of U.S. and
international patents, including patents related to non-invasive
nerve stimulation with mobile devices, providing expanded IP
coverage; the possibility of future business models, the potential
of nVNS generally and gammaCore in particular and other statements
that are not historical in nature, particularly those that utilize
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:ECOR Investor
Relations(973) 302-9253investors@electrocore.com
1 Camilleri, M; Parkman HP; Shafi MA; Abell T; Gerson L.
Clinical guideline: management of gastroparesis. 2013 Jan; 108 (1):
18-37. 2 Rey E, Choung RS, Schleck CD, Zinsmeister AR, Talley
NJ, Locke GR III. Prevalence of hidden gastroparesis in the
community: the gastroparesis“iceberg”. J Neurogastroenterol Motil.
2012;18:34–42.3 Lacy BE, Crowell MD, Mathis C, Bauer D, Heinberg
LJ. Gastroparesis: quality of life and health care utilization. J
Clin Gastroenterol. 2018; 52: 20–24.4 Harer, K; Pasricha PJ.
Chronic Unexplained Nausea and Vomiting or Gastric Neuromuscular
Dysfunction (GND) An Update on Nomenclature, Pathophysiology and
Treatment and Relationship to Gastroparesis. 2016 Dec; 14 (4):
410-419.5 Mayo Clinic Arizona6 Johns Hopkins University7 NAMSA
(North America Science Associates)8 Nisola Consulting
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/8fcab29c-b71f-4485-a2f3-2427e9f8b2e3
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