FDA OKs remote electrical neuromodulation device in children with migraine
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The FDA has expanded the approval of a remote electrical neuromodulation device to treat episodic and chronic migraine in children aged 12 years and older, according to a press release issued by the manufacturer.
Nerivio (Theranica) was initially approved by the FDA to treat episodic migraine in adults. The approval was expanded in October 2020 for the treatment of chronic migraine in adults following the results of two clinical trials presented at PAINWeek.
“Having this drug-free migraine therapy available for the adolescent migraine community could positively impact patient compliance,” Jennifer McVige, MD, MA, a board-certified physician in pediatric neurology, adult and pediatric headache and neuroimaging at the DENT Neurologic Institute, said in the press release. “Teens do not always want to take pills, and some may be unable to do so due to various contraindications.”
McVige added that as adolescents typically adapt easily to new technology, “Nerivio is an efficacious smartphone-controlled tech solution that can be worn inconspicuously and is the perfect design for teens who may unfortunately begin to experience migraine attacks.”
The device is worn on a patients’ upper arm for 45 minutes and uses remote electrical neuromodulation to activate the brain’s conditioned pain modulation mechanism.
McVige and colleagues who conducted the study that led to the extended approval of the device in children found that 71% of adolescent patients who used the device had headache relief in 2 hours and 35% had complete freedom from pain. In 90% of these patients, pain relief and freedom lasted 24 hours.
The study, published in Headache, also found that 69% of adolescents had improved functional ability at 2 hours, and no serious adverse events were identified.
“This new indication is a dramatic step in our committed effort to serve the migraine community as a whole,” Alon Ironi, CEO of and co-founder of Theranica, said in the press release.
“Teens are one of the most vulnerable migraine populations and we are happy to provide them with a user-friendly tool to get them back to their daily lives as quickly as possible,” he added.
References:
Hershey AD, et al. Headache. 2020;doi:10.1111/head.14042.