electroCore Announces Regulatory Approval in Canada to Treat Adolescent Migraine
electroCore has received an amended Medical Device License from Health Canada for gammaCore nVNS to treat migraine in adolescents aged 12-17. This expansion allows for both acute and preventive treatment of migraine, providing a non-drug option in a field with limited treatments for young patients. The decision is based on positive data, including a study showing 46.8% attack resolution without additional medication. The device is now available in Canada through RSK Medical Inc., enhancing options for managing primary headache disorders.
- Health Canada approved gammaCore for acute and preventive migraine treatment in adolescents.
- Offers a non-medication treatment option for migraine, addressing a significant gap in adolescent care.
- Efficacy data supports its use, with a study indicating 46.8% successful resolution of migraine attacks.
- None.
Health Canada expands gammaCore label to include the acute and preventive treatment of migraine in adolescents
ROCKAWAY, NJ, Oct. 14, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that the company received an amended Medical Device License from Health Canada to expand the label of gammaCore nVNS to include the acute and preventive treatment of migraine in adolescents between 12 and 17 years of age. gammaCore is now cleared for most forms of primary headache including the acute and preventive treatment of migraine in adolescents and adults, as well as the acute and preventive treatment of cluster headache in adults.
"Migraine affects approximately 1 in 10 adolescents and is one of the most disabling diseases worldwide. Despite this, evidence-based treatment options for adolescents with migraine are limited. It is exciting to see a new treatment option for Canadian adolescents with migraine, particularly as gammaCore offers a non-medication option to families,” said Dr. Serena Orr,
headache specialist, pediatric neurologist, and researcher at the Cumming School of Medicine, University of Calgary, Canada. “There is supportive efficacy and safety data in adults for the acute and preventive treatment of migraine and promising pediatric safety data. As adoption increases within the adolescent population, additional data will be generated which will be helpful in understanding how effective it is for adolescents.”
“Prescribers and the parents of adolescent migraine sufferers now have a non-drug treatment option, that is approved for the acute and preventive management of migraine in adolescents,” said Iain Strickland, Vice President of Global Sales and Strategy at electroCore, Inc. “gammaCore represents a unique treatment for adolescents with migraine, who along with their families would often prefer to avoid the use of prescription drugs.”
The label expansion was based on previously reported randomized controlled trials of gammaCore for the acute and preventive treatment of migraine and was supported by a small study (n=9) in adolescents where
gammaCore SapphireTM is available in Canada through our exclusive distributor, RSK Medical Inc., for patients suffering with primary headache disorders.
For more information, visit https://rskmedical.com.
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 gammaCoreTM
gammaCoreTM (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 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. 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
Forward-Looking Statements
This 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; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the business, operating or financial impact of such studies; the potential of nVNS generally and gammaCore in particular for the acute and preventative treatment of migraine in adolescence in the Unites States and Canada 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.
1 Grazzi L, Egeo G, Liebler E, Padovan AM, Barbanti P. Non-invasive vagus nerve stimulation (nVNS) as
symptomatic treatment of migraine in young patients: a preliminary safety study. Neurol Sci. 2017 May;38(Suppl
1):197-199. doi: 10.1007/s10072-017-2942-5. PMID: 28527086.
FAQ
What recent approval did electroCore receive for gammaCore?
What age group is now eligible for treatment with gammaCore?
What kind of treatment does gammaCore provide for migraines?
What was the success rate of migraine attack resolution in the study for gammaCore?
Who distributes gammaCore in Canada?
