FDA Allows Marketing of First Device to Treat Migraine Pain
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iStock/Thinkstock(NEW YORK) — The U.S. Food and Drug Administration allowed marketing of the first device to relieve pain caused by migraine headaches.
The new device, the Cerena Transcranial Magnetic Stimulator or TMS, is a prescription instrument used after the onset of pain from a migraine. The attacks are preceded by an “aura,” according to the FDA, where a visual, sensory or motor disturbance may prompt the instance.
The Cerena TMS is held by the user onto the back of the head, and a pulse of magnetic energy stimulates the brain in an attempt to stop or lessen the pain.
Following a clinical trial of 201 patients with moderate-to-strong migraine headaches preceded by an aura, the FDA found support for marketing authorization of the device.
Studies showed nearly 38 percent of subjects who used the Cerena TMS were pain-free two hours after using it. However, it did not show the device was effective in relieving symptoms associated with migraines such as sensitivity to light or sound.
Migraine headaches are accompanied by intense pulsing or throbbing pain in one area of the head and can last anywhere between four and 72 hours when untreated, according to the FDA.
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