FDA Approves Nerivio, Preventive Migraine Treatment

The FDA has green lit Theranica's Nerivio, remote electrical neuromodulation device for preventing migraines.

The FDA has authorized Nerivio as a dual-use acute and preventive treatment for migraines in people 12 or older with or without aura.

The treatment is drug-free, self-administered, and controlled with a smartphone. Nerivio wraps around the upper arm and uses non-painful remote electrical modulation (REN) to activate peripheral nerves. This way, the device induces the internal pain management mechanism called conditioned pain modulation (CPM) in remote body regions. Such a treatment session lasts 45 minutes.

Nerivio is recommended to use every other day for prevention or at the start of a migraine attack for acute treatment.

The FDA's approval is based on a controlled clinical trial, where REN reduced the number of migraine days by 4.0 days per month, compared to a reduction of only 1.3 days in the placebo group. Among participants with episodic migraine — headaches occurring fewer than 15 days a month — REN decreased migraines by 2.3 days a month.

The treatment also reduced chronic migraine by 3.0 days a month. This type of migraine is characterized as headaches on at least 15 days per month, with the features of migraine on at least 8 days per month.

The study, published in the journal Headache, included 248 participants, most of whom (85.9%) were female. The research authors concluded that REN offers a safe and effective alternative to pharmacological treatments in migraine prevention.

"The trial data demonstrates Nerivio can now cover the full treatment spectrum and provide access to migraine prevention and relief, especially for the adolescent population, who have a strong preference for clinically effective, drug-free treatment solutions," says Andrew Blumenfeld, M.D., Director of the Los Angeles Headache Center and a co-author of the paper.

Drugs are not for everyone

About 35 million Americans suffer from migraines, the most prevalent neurological disorder in the world with no cure. The primary symptom of the disease is a severe headache, which can be accompanied by nausea, disturbed vision, or increased sensitivity to light and sound.

There is a wide variety of pharmacological treatments for migraine, but they are associated with side effects, and not everyone can use them. Common acute and preventative migraine treatments include:

Over-the-counter painkillers, such as aspirin or ibuprofen, are most effective when taken at the very beginning of an attack.

Triptans, such as Imitrex, Amerge, or Maxalt, are painkillers designed specifically to treat migraine headaches. They work by causing the dilated blood vessels around the brain to contract.

Beta-blockers, medications used to reduce blood pressure, can also be used in migraine treatment and prevention.

Calcitonin Gene-Related Peptide Receptor (CGRP) antagonists are designed to treat migraines by targeting calcitonin gene-related peptides. During migraine attacks, this substance is elevated in blood serum.

Botox can reduce the number of migraine days when injected into the space between nerve synapses.