Theranica Receives FDA 510(k) for Migraine Prevention Device

Theranica, a prescribed digital therapeutics company, has announced that the Nerivio prescription wearable has recently received Food and Drug Administration (FDA) clearance as a dual-use acute and preventive treatment for migraine with or without aura in people 12 years of age or older. 

In a randomized placebo-controlled study, the drug-free Nerivio wearable, used every other day, demonstrated significant reduction in monthly migraine days and other prevention endpoints.

Nerivio previously received clearance as an acute treatment for migraine in the same patient population, based on previous clinical studies demonstrating consistent relief of pain and associated migraine symptoms.

Research shows that for some people, prescription drugs can be poorly tolerated or ineffective. In addition, if consumed too frequently, some drugs may lead to medication overuse headache. Nerivio offers an alternative drug-free treatment.

Nerivio is a novel, physician-prescribed treatment for migraine that is discreet and non-disruptive to everyday living. Controlled with a smartphone and self-administered, Nerivio wraps around the upper arm and uses non-painful remote electrical modulation (REN) to activate peripheral nerves, inducing the internal pain management mechanism called conditioned pain modulation (CPM) in remote body regions. In simpler terms, the upper arm is stimulated to control the migraine pain in the head. Each treatment lasts 45 minutes and is recommended for use every other day for prevention or at the start of a migraine attack for acute treatment.

With Nerivio's new dual-use indication, patients may use the wearable more frequently in an effort to proactively prevent migraines. To better support existing and new Nerivio users alike, Theranica is increasing the migraine treatments per unit by 50% from 12 to 18 treatments.

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