electroCore Announces Publication of PREMIUM II Trial of gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) for the Prevention of Migraine
10 Janeiro 2022 - 6:01PM
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage
bioelectronic medicine company, today announced the publication of
a peer-reviewed paper, entitled “Non-invasive vagus nerve
stimulation for prevention of migraine: The multicenter,
randomized, double-blind, sham-controlled PREMIUM II trial” in
Cephalalgia, the official journal of the International
Headache Society (IHS). The paper reports the results of a
randomized, double-blind, sham-controlled trial conducted at
twenty-seven sites across the United States. Originally designed
and powered to randomize 400 patients, the study was closed early
due to COVID-19 after enrolling 231 subjects.
The results of the study showed a decrease in the number of
monthly headache days of 4.6 vs. -3.0 for sham (p=0.05) with 44.87%
of subjects in the gammaCore group having greater than a 50%
reduction in the number of migraine days per month compared with
26.81% for the sham group (p=0.05). Quality of life, as measured by
the HIT-6 (Headache Impact scale), improved by -4.9 points vs. -2.3
for sham (p<0.05). In the subpopulation of patients diagnosed
with migraine with aura, the number of headache days decreased by
5.5 days in the nVNS group compared with 2.7 in the sham group
(p=0<0.05), a therapeutic gain of >100% compared to sham.
These findings are consistent with previous reports on the
mechanisms of action that suggest nVNS may be particularly
effective in patients with migraine with aura.
Dr. Umer Najib, Associate Professor, Program Director of
the Headache Medicine Fellowship Program at the West Virginia
University and first author of the paper commented, “We are pleased
to have added to the data that helps suggest the types of migraine
patients who could likely benefit most from nVNS. The safety and
tolerability of nVNS is such that it can be used as a stand-alone
or adjunctive treatment, depending on the needs of the patient, and
its flexibility allows health care providers to consider it for
many of their patients.”
“We congratulate and thank all of the investigators, site
staff, and subjects who conducted this study throughout the United
States despite the challenges that arrived with COVID-19,”
commented Eric Liebler, Senior Vice President of Neurology at
electroCore. “With seven different indications from the FDA,
gammaCore is safe and effective for many patients with primary
headache, and the findings of this study highlighting the potential
benefits in patients who have migraine with aura are particularly
compelling.”
The full publication is available
at: https://journals.sagepub.com/doi/10.1177/03331024211068813
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 gammaCoreTMgammaCoreTM
(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 (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
Please refer to the gammaCore Instructions for Use for all of
the important warnings and precautions before using or prescribing
this product.
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 with respect to enrollment in
ongoing studies); 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 providing expanded IP coverage; the
possibility of future business models and revenue streams from the
company’s potential utilizing nVNS for symptoms associated with
migraine with aura, 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," "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.
Investors:Rich CockrellCG
Capital404-736-3838ecor@cg.capital
or
Media Contact:Jackie
DorskyelectroCore908-313-6331jackie.dorsky@electrocore.com
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