electroCore Inc, a commercial-stage bioelectronic medicine company, announced that the company received Section 510(k) clearance from the Unites States Food and Drug Administration (FDA) of the company's submission 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.
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. For further information see the IDTechEx report on Bioelectronic Medicine 2019-2029.
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.
Dr. Andrew Hershey, Endowed Chair and Director of Neurology at Cincinnati Children's Medical Center and Professor of Pediatrics and Neurology at the University of Cincinnati College of Medicine, commented, "Migraine is a very common disease in adolescents that can affect them at home, school and socially. gammaCore, which can be used acutely to treat migraine attacks, or when used daily can decrease the number of attacks, is an exciting treatment that I look forward to offering to my adolescent patients."
It is estimated that 10% of all school age children and up to 28% of teens between the ages of 15-19 live with migraine, while 37% of children find their schoolwork suffers during a headache which can negatively affect a teen's social life.
"gammaCore (nVNS) is the only treatment option, drug or device, that is currently available for the acute and preventive treatment of migraine in adolescents," said Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. "With their interest in technology and desire to avoid prescription drugs, gammaCore represents a unique treatment for adolescents with migraine. We would like to thank the Division of Neuromodulation and Physical Medicine Devices and their colleagues at the FDA for their efforts to review and clear the expanded label for gammaCore."
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.
Source and top image: electroCore