FDA grants de novo approval of Nerivio Migra for migraine.
Theranica announced that the FDA granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilizing Remote Electrical Neuromodulation for the acute treatment of migraine. Placed on the upper arm, the Nerivio Migra uses smartphone-controlled electrical pulses to create a Conditioned Pain Modulation (CPM) response and is a first-in-category product. The Nerivio Migra can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs.
The FDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.
Comment: Nerivio Migra is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.
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