Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older.
The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (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. Sixty-nine percent of the patients experienced 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.