Nerivio, currently indicated for use in ages
12 and older, demonstrates study results in younger children
with migraine.
BRIDGEWATER, N.J. and
NETANYA, Israel,
July 25,
2024 /PRNewswire/ -- Theranica, a neuromodulation
therapeutics company, today announced that Annals of the Child
Neurology Society has published results from a prospective
real-world evidence study evaluating the safety and efficacy of
remote electrical neuromodulation (REN) as a treatment for migraine
in children ages 6 to 11. The Nerivio® REN wearable is
the first FDA-cleared, non-drug, easy-to-use treatment for
both acute migraine attacks and prevention of migraine with or
without aura in adolescents and adults ages 12 and older. The
treatment is currently under FDA review to possibly expand the
indication to eight years of age and older.
"This study has shown that REN is a
valuable tool for migraine treatment even in younger children,"
said Dr. Trevor Gerson, MD, Headache
Specialist, Children's Mercy Kansas City.
This recently published clinical study, involving 293 children
aged 6 to 11, has shown promising results regarding the safety and
effectiveness of the Nerivio REN wearable device as a
non-pharmacological treatment for migraine.
At two hours post-treatment, 72.2% of patients reported pain
relief, 36.0% achieved pain freedom, 83.3% experienced functional
disability relief, and 38.9% attained functional disability
freedom. Notably, 67.4% of treatments did not require a second
session within 24 hours, indicating low recurrence rates. The
device was used as a standalone treatment in 45.1% of
cases and combined with over-the-counter medications in
34.2%, with 79.3% of treatments avoiding use of
prescribed medications altogether. No adverse events were reported,
underscoring the REN wearable's safety.
Dr. Klaus Werner, Associate
Professor of Pediatrics and Child Neurology at Duke University, stated, "What motivated my
colleagues and me at our clinic to explore the use of REN with our
young patients is the combination of limited options for treating
young children and the high safety of this novel drug-free therapy,
which we experienced when treating adolescents."
"This study has shown that REN is a valuable tool for migraine
treatment even in younger children," said Dr. Trevor Gerson, MD, Headache Specialist,
Children's Mercy Kansas City, who was one of the authors of the
study paper.
Migraine is a neurological disease that has no cure and affects
1 billion people worldwide, including 100 million adolescents.
People with migraine disease need acute, and often also preventive
treatment. Additionally, early-onset migraine, particularly before
age 12, may be a predictor of chronic migraine in adulthood,
highlighting the need for effective interventions during this
critical developmental period.
"At Theranica, we are focused on developing therapies for people
with migraine who face limitations in using traditional drug
treatments, with adolescents being a significant part of that
segment," said Dr. Alit Stark Inbar,
neuroscience PhD, Vice President of Medical Information at
Theranica, and co-author of the study. "With young patients in
mind, we meticulously developed the Nerivio REN wearable ensuring
it could be used safely and discreetly at school and without
disrupting their daily activities. Our goal now is to build on the
successful use of the Nerivio REN wearable and - subject to future
FDA clearance - be able to offer this treatment to ages even
younger than 12, who have less options for treating the
disease."
For more information about how the Nerivio REN wearable can
support complete migraine care and to download a prescription form,
please visit Nerivio.com.
About Nerivio
Controlled by a smartphone app and
self-administered, the Nerivio REN wearable is a complete migraine
care treatment that wraps around the upper arm and uses sub-painful
Remote Electrical Neuromodulation (REN) to activate nociceptive
nerve fibers in the arm. These fibers send signals that trigger a
descending pain management mechanism in the brain called
conditioned pain modulation (CPM), which turns off migraine pain
and associated symptoms without medication. In simpler terms, the
upper arm is stimulated to unleash a natural process in the brain
to abort or relieve migraine headaches and other associated
symptoms. Each treatment lasts 45 minutes and is applied every
other day for prevention or at the start of a migraine attack for
acute treatment.
About Theranica
Theranica is a neuromodulation
therapeutics company dedicated to creating effective, safe,
affordable, low-side-effect therapies for idiopathic pain
conditions. The company's award-winning flagship wearable,
Nerivio®, is the first FDA-cleared prescribed migraine REN wearable
for acute and/or preventive treatment of migraine. Nerivio has been
used in more than 850,000 migraine treatments in the U.S.,
including by adolescents and veterans. Over the last 9 months
Nerivio's availability under prescription was expanded to
India, Germany, Spain, South
Africa and the UK. Learn more by visiting our
websites, theranica.com and nerivio.com, and following us
on LinkedIn, X (formerly Twitter), Instagram and
Facebook.
#NoMatterWhat
Theranica Contact:
Ronen Jashek
ronenj@theranica.com
+972-72-390-9750
Media Contact:
Jennifer
Sefakis
Grey Matter Marketing
jennifer@greymattermarketing.com
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SOURCE Theranica