Sam Brusco, Associate Editor02.16.21
electroCore received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand gammaCore nVNS’ label to include acute and preventive migraine treatment in adolescents between 12 and 17 years old. It’s now cleared for most forms of primary headache including acute and preventive migraine treatment in adolescents and adults, as well as 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 10 percent of all school age children and up to 28 percent of teens between the ages of 15-19 live with migraine1, while 37 percent of children find schoolwork suffers during a headache, which can negatively affect social life.2
“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 acute and preventive migraine treatment. This was supported by a small study (n=9) in adolescents where 46.8 percent of all treated attacks were successfully resolved without acute rescue medication.3
References
1 https://migraineresearchfoundation.org/about-migraine/migraine-in-kids-and-teens/
2 https://mhni.com/headache-pain-faq/pediatric-headaches/managing-headaches-school#:~:text=Headache%20can%20affect%20how%20well,of%20their%20adolescent%20headache%20patients.
3 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(Suppl1):197-199. doi: 10.1007/s10072-017-2942-5. PMID: 28527086.
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 10 percent of all school age children and up to 28 percent of teens between the ages of 15-19 live with migraine1, while 37 percent of children find schoolwork suffers during a headache, which can negatively affect social life.2
“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 acute and preventive migraine treatment. This was supported by a small study (n=9) in adolescents where 46.8 percent of all treated attacks were successfully resolved without acute rescue medication.3
References
1 https://migraineresearchfoundation.org/about-migraine/migraine-in-kids-and-teens/
2 https://mhni.com/headache-pain-faq/pediatric-headaches/managing-headaches-school#:~:text=Headache%20can%20affect%20how%20well,of%20their%20adolescent%20headache%20patients.
3 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(Suppl1):197-199. doi: 10.1007/s10072-017-2942-5. PMID: 28527086.