FDA grants 510(k) clearance for vagus nerve stimulation device in adolescent migraine

The FDA granted 510(k) clearance to electroCore to expand the approval of gammaCore, the company’s non-invasive vagus nerve stimulation, for the acute and preventative treatment of adolescent migraine, according to a press release.

The expanded approval applies to children aged 12 to 17 years, the release noted. With this approval, gammaCore (electroCore) is now cleared to treat most forms of primary headache, including acute and preventive treatment of migraine in adolescents and adults, as well as acute and preventive treatment of cluster headaches in adults.

According to the release, gammaCore is the only treatment available for acute and preventative treatment of adolescent migraine. The FDA based the expanded approval on prior trials of gammaCore, as well as a small study of 9 adolescent patients in which 46.8% of all treated attacks resolved successfully without the use of rescue medication.

“With their interest in technology and desire to avoid prescription drugs, gammaCore represents a unique treatment for adolescents with migraine,” Eric Liebler, senior vice president of neurology at electroCore, said in the release.