The drug will be marketed for acute treatment of episodic or chronic migraine in people 12 years and older
US-Israeli prescribed digital therapeutics firm Theranica, a company that develops advanced electroceuticals for migraine and other pain conditions has received clearance from the US Food and Drug Administration to market its device for the acute treatment of episodic or chronic migraine in people 12 years and older.
Theranica combines electrical neurostimulation and neuromuscular-stimulation technologies with modern wireless communication and smartphone applications The company leverages these advanced technologies to design and deliver effective products for treating a variety of severe and common medical problems.
Theranica’s Nerivio Migra, which won FDA De Novo clearance in May 2019, is a migraine-relief patch that provides migraine treatment through neuromodulation. Patients can attach Theranica’s clinically tested, wearable patch on their upper arm for up to 45 minutes and launch a personalised pain-relief programme.
Ten per cent of all school-age children and up to 28 per cent of teens between the ages of 15 to 19 live with migraine. 37 per cent of children find that their schoolwork suffers during a headache.
The use of the device in the treatment of adolescents is supported by a study recently published in the journal Headache. According to the study published in Headache, 71 per cent of the adolescent participants using Nerivio experienced pain relief after two hours while 35 per cent experienced complete freedom from pain. Pain relief and pain freedom were sustained for 24 hours in 90 per cent of cases. 69 per cent of the patients experienced an improvement in their functional ability, defined by the 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.