With any brains at all in the stroke medical world this would be being tested in stroke survivors.
But there are no brains in stroke, you're screwed.
– First U.S. Food and Drug Administration (FDA) release for electroCore, a neuroscience and technology company
– Hand-held, non-invasive, easy-to-use device provides new option for
the approximately 400,000 Americans living with this rare but extremely
debilitating headache disorder
Basking Ridge, NJ, April 18, 2017 – electroCore, a
neuroscience and technology company dedicated to improving patient
outcomes through technological advancement, announced today that the
U.S. Food and Drug Administration (FDA) released the use of gammaCore
®
(non-invasive vagus nerve stimulator) for the acute treatment of pain
associated with episodic cluster headache in adult patients. gammaCore
transmits a mild electrical stimulation to the vagus nerve through the
skin, resulting in a reduction of pain. This is the first FDA product
release for electroCore in the U.S.
“Cluster headache is a rare, debilitating and difficult to treat
disorder with few effective acute therapies,” said Stephen Silberstein,
MD, Director, Headache Center, Jefferson University, Philadelphia, PA.
“The FDA release of gammaCore is an important advance in the treatment
of the pain associated with cluster headache. It is a way for patients
to treat their symptoms as often as they need to use the device. It does
not have the side effects or dose limitations of commonly prescribed
treatments or the need for invasive implantation procedures, which can
be inconvenient, costly and high-risk.”
The FDA release of gammaCore is based on subgroup analyses from two
trials in the ACT (Non–Invasive Vagus Nerve Stimulation for the ACute
Treatment of Cluster Headache) clinical trial program evaluating the
safety and efficacy of gammaCore for the acute treatment of episodic
cluster headache.
i Both trials (ACT1 and ACT2) were
prospective, double-blind, placebo-controlled, randomized studies
evaluating the use of gammaCore versus placebo.
i Results from
ACT1, evaluating 85 patients with episodic cluster headache, found that
34.2% of patients experienced a reduction in pain from episodic cluster
headache (defined as the percentage of patients who reported mild or no
pain 15 minutes after treatment initiation with gammaCore for the first
treated cluster headache attack in the study; use of rescue medication
within 60 minutes was considered a treatment failure) compared to 10.6%
in patients treated with placebo (p=0.008).
ii Results from
ACT2, evaluating 182 attacks in 27 patients with episodic cluster
headache, also found that a significantly higher percentage of attacks
were pain-free (defined as pain-free at 15 minutes after the onset of
pain from cluster headache with no use of rescue medication through the
30-minute treatment period) in patients treated with gammaCore (47.5%)
versus placebo (6.2%; p=0.003).
i In both trials, gammaCore
was found to be safe and well-tolerated, with the majority of adverse
events (AEs) being mild and transient and occurring during the time of
active treatment.
i
“The U.S. release of gammaCore for the acute treatment of pain
associated with episodic cluster headache in adult patients is a major
milestone for electroCore, as it not only marks electroCore’s first
FDA-released product, but also underscores our company vision to improve
patient outcomes through technological advancements,” said Francis R.
Amato, Chief Executive Officer of electroCore. “We are leading the way
for the future of medicine through the development of
patient-administered, non-invasive vagus nerve stimulation therapy, and
we look forward to bringing gammaCore’s breakthrough technology to
patients in the U.S.”
gammaCore is currently in use outside of the U.S., including in the
European Union. In the U.S., electroCore expects commercial availability
of gammaCore early in the third quarter of 2017.
About gammaCore®
gammaCore
® is the first non-invasive, hand-held medical
device applied at the neck that acutely treats the pain associated with
episodic cluster headache in adult patients through the transmission of a
mild electrical stimulation to the vagus nerve through the skin.
Designed as a portable, easy-to-use technology, gammaCore can be
self-administered by patients as needed to provide relief for the
treatment of pain associated with episodic cluster headache without the
potential side effects associated with standard of care. When placed on a
patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s
afferent fibers resulting in the modification of pain signals.
gammaCore is CE-marked in the European Union for the acute and/or
prophylactic treatment of primary headache (Migraine, Cluster Headache,
and Hemicrania Continua) and Medication Overuse Headache in adults.
gammaCore is also released/cleared, licensed, registered and/or approved
in Australia, Canada, Colombia, Hong Kong, India, New Zealand, South
Africa, and Vietnam. In Germany, gammaCore is distributed by Desitin.
About Cluster Headache
Cluster headache is a rare but extremely painful primary headache
disorder characterized by recurring unilateral attacks. The condition is
the least common type of headache disorder, occurring in approximately 1
to 2 out of 1,000 individuals.
iii Cluster headache predominantly affects males, with symptoms typically manifesting by the age of 30.
iv
Frequently nicknamed “suicide headache” due to the severity of pain
associated with their occurrence, cluster headache bouts occur rapidly
and with variable frequency but often at the same time each year or day
and are often more frequent at night.
v Those at greater risk of cluster headache include heavy smokers and those with a family history of the condition.
iii
About electroCore
electroCore LLC is a U.S.-based neuroscience and technology company
dedicated to improving patient outcomes through technological
advancement and focused on developing a non-invasive vagus nerve
stimulation therapy (gammaCore) for the treatment of multiple conditions
in neurology, inflammation, and metabolic syndrome. The company’s
initial target is the treatment of primary headache (migraine and
cluster headache) and the associated chronic co-morbidities of gastric
motility, psychiatric, sleep, and pain disorders that drive
disproportionately large direct and indirect costs within the healthcare
system and society.
For more information, visit electrocore.com.
IMPORTANT SAFETY INFORMATION
Safety and Efficacy of the gammaCore device has not been evaluated in
the following patients, and therefore is NOT indicated for:
• Patients with an active implantable medical device, such as a
pacemaker, hearing aid implant, or any implanted electronic device
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
(This is likely most of us)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
• Pediatric patients or pregnant women
Do not use gammaCore if you:
• have a metallic device such as a stent, bone plate, or bone screw implanted at or near your neck
• are using another device at the same time (e.g., TENS Unit, muscle
stimulator) or any portable electronic device (e.g., mobile phone)
Refer to the gammaCore Instructions for Use for all important warnings and precautions before using this product.
Media Contact
Maura Siefring
GCI Health
(215) 837-8450
