FDA Approves Theranica's Nerivio® for Acute Treatment of Migraine in Adolescents
NETANYA, Israel and MONTCLAIR, N.J., Jan. 25, 2021 /PRNewswire/ -- Theranica Ltd., a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® therapeutic device has received the Food and Drug Administration clearance to market for an expanded indication for acute treatment of episodic or chronic migraine in people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache.
10% of all school age children and up to 28% of teens between the ages of 15-19 live with migraine. 37% of children find that their schoolwork suffers during a headache and it can negatively affect a teen's social life as well.
"Having this drug-free migraine therapy available for the adolescent migraine community could positively impact patient compliance," said Dr. Jennifer McVige, a board-certified physician in pediatric neurology, adult and pediatric headache and neuroimaging at the DENT Neurologic Institute, who was one of the investigators in the clinical study which led to this indication expansion. "Teens do not always want to take pills, and some may be unable to do so due to various contraindications. Additionally, teens tend to easily adapt to tech. 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. As a mother of two teenagers with migraine, and someone who sees many adolescents in my practice, Nerivio is a promising new option with potential to help thousands of young patients."
According to the study published in Headache, 71% of the adolescent participants using Nerivio experienced pain relief after two hours while 35% experienced complete freedom from pain. Pain relief and pain freedom were sustained for 24 hours in 90% of cases. 69% of the patients experienced improvement in their functional ability, defined by ability to do schoolwork and perform "usual activities," at two hours. There were no device-related serious adverse events.
"This new indication is a dramatic step in our committed effort to serve the migraine community as a whole," said Theranica's CEO and co-founder Alon Ironi. "Throughout 2020, we continued pursuing clinical data regarding how Nerivio can help this all-too-large patient population. As a result, Nerivio is now widely available as a drug-free alternative to treat migraine. 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."
Theranica's FDA-cleared prescribed therapeutic wearable Nerivio® is worn on the upper arm for 45 minutes, and utilizes Remote Electrical Neuromodulation to activate the brain's native Conditioned Pain Modulation mechanism to treat pain and associated migraine symptoms. Nerivio was cited as one of TIME's best inventions of 2019.
Eligible for insurance coverage, Nerivio is available by prescription by any licensed healthcare provider including via telemedicine platforms such as Cove and UpScript. Nerivio is delivered directly to the patient's home. Every Nerivio unit is good for 12 treatments, after which it can be recycled, and the prescription refilled with a new device.
Theranica is a prescribed digital therapeutics company dedicated to creating effective, safe, affordable, low side-effect electroceuticals for idiopathic pain conditions. The company's award-winning flagship product, Nerivio®, is the first FDA-cleared smartphone-controlled prescription wearable device for acute migraine treatment of episodic or chronic migraine in people 12 years and older. Theranica is expanding its proprietary technology to offer additional solutions for other pain conditions. The Nerivio has received FDA authorization and the CE mark for use in acute treatment of migraine.
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