FDA Approves First Device to Treat Migraines

The US Food and Drug Administration (FDA) has approved the first device to ease the pain of migraines preceded by aura.

The prescription-only Cerena Transcranial Magnetic Stimulator device is used by holding it against the back of the head and pressing a button to release a pulse of magnetic energy that stimulates the brain’s occipital cortex, which may stop or ease migraine-caused pain.

Produced by eNeura Therapeutics in Sunnydale, CA, the device is only approved for use in adults and should not be used by people with suspected or diagnosed epilepsy or a family history of seizure. It is not intended to be used more than once every 24 hours, and it is also not approved for use against other symptoms of migraine.

The device’s approval was based on a clinical trial of 201 patients with moderate to strong migraine with aura. Of those patients, 113 tried to treat their migraines while an attack was in progress. More than a third of those who used the stimulation device said they were pain free 2 hours later, compared to 17% who did not use the device. A day after the onset of migraine, nearly 34% of patients who used the device were pain free, compared to 10% of people who had not used it.

While side effects were rare in the trial, they included single reports of sinusitis, aphasia, and vertigo.