Remote Electrical Neuromodulation Device Cleared by FDA for the Acute Treatment of Migraine in Adolescents

Neuromodulation device available for episodic and chronic migraine patients aged 12 years and older

On January 25, 2021, the FDA cleared an expanded indication for the remote electrical neuromodulation (REN) Nerivio® device for the acute treatment of patients with episodic and chronic migraine aged 12 years and older.

The REN device received its initial approval in October 2020 for patients 18 years and older. The device is the first smartphone-controlled prescription wearable device for the acute treatment of migraine.

Clinical Trials

The FDA cleared the REN device based on data from a single-arm, multicenter study of adolescents with migraine aged 12 to 17 years. In the study, 45 participants with episodic and chronic migraine completed a test treatment with the REN device. Researchers reported only one device-related adverse event where a patient experienced a temporary feeling of pain in their arm.

Research published in Headache® showed pain relief and freedom from pain at two hours were achieved by 71% and 35% of participants, respectively. The pain relief and pain freedom lasted for 24 hours in 90% of the cases. In addition to this, 69% of participants found improvements in functional ability, such as the ability to do schoolwork or perform usual activities, at two hours.

Device Details

The REN device prescription is good to use for 12 treatments, after which patients can get  to fill the prescription. Patients apply the device onto their upper arm, then use it at the onset of a migraine or aura symptoms.

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This article is notice of a new approval, not intended to be an endorsement of a particular product and/or treatment modality.