ROCKAWAY, N.J., Feb. 16, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that on Friday, February 12, 2021, 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.
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.
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.
Recent clinical experiences and clinical trials have demonstrated the safety, tolerability, and efficacy of non-invasive vagus nerve stimulation (nVNS; gammaCore®) for the acute and prophylactic treatment of migraine. nVNS has a favorable adverse event profile, making it an attractive option for sensitive patient populations. We explored the safety, tolerability, and efficacy of nVNS as acute migraine treatment in adolescents. A group of adolescent patients suffering from migraine without aura were trained to use gammaCore to manage their migraine attacks. 46.8% of the treated migraine attacks (22/47) were considered successfully treated and did not require any rescue medication. No device-related adverse events were recorded. This preliminary study suggests that nVNS may represent a safe, well-tolerated, and effective for acute migraine treatment in adolescents.