electroCore Announces Regulatory Approval in Canada to Treat Adolescent Migraine
"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.
headache specialist, pediatric neurologist, and researcher at the
“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
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 46.8% of all treated attacks were successfully resolved without the use of any acute rescue medication.1
gammaCore SapphireTM is available in
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.
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
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
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
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.
Rich Cockrell CG Capital404-736-3838 firstname.lastname@example.org or Media Contact: Jackie DorskyelectroCore 908-313-6331 Jackie.email@example.com