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electroCore Announces Regulatory Approval in Canada to Treat Adolescent Migraine
Health Canada expands gammaCore label to include the acute and preventive treatment of migraine in adolescents ROCKAWAY, NJ, Oct. 14, 2021 (GLOBE NEWSWIRE) --
About this update from Electrocore, Inc.
[{"type":"text","content":"Health Canada expands gammaCore label to include the acute and preventive treatment of migraine in adolescents\nROCKAWAY, 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 46.8% of all treated attacks were successfully resolved without the use of any acute rescue medication.1 gammaCore SapphireTM is available in Canada through our exclusive distributor, RSK Medical Inc., for patients...