Pharmaceutical

FDA approves magnetic device for treating migraines preceded by auras

fda logo FDA approves magnetic device for treating migraines preceded by aurasA new, magnetic device has been approved by the Food and Drug Administration (FDA) to relieve pain caused by migraine headaches proceeded by an aura.

Migraines are a common type of headache that often occur with symptoms such as nausea, vomiting or sensitivity to light. In many people, a throbbing pain is felt only on one side of the head. Migraines can last anywhere between 4 to 72 hours if left untreated.

About a third of migraine suffers experience warning symptoms, called an aura, before the actual headache begins. Auras produce strange symptoms such as dizziness, ringing in the ears, seeing zigzag lines, blind spots, or light sensitivity before the pain of a headache begins.

The Cerena Transcranial Magnetic Stimulator, or Cerena TMS, is a prescription device made by eNeura Therapeutics, that is designed to be used after the onset of headaches that are proceeded by auras. Using both hands, patients hold the device against the back of their head and press a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain. This is thought to stop or lessen the pain associated with migraines preceded by auras.

The device was approved based on data from a randomized clinical trial of 201 patients who reported having mostly moderate to strong migraine headaches and who had experienced auras before their headaches at least 30 percent of the time. Among participants, about 113 reported treating a migraine at least once when pain was present.

Data showed that about 38 percent of the 113 participants who used the Cerena TMS device when they had migraine pain were pain-free two hours later compared to about 17 percent of patients who did not use the device. After 24 hours, about 34 patients who used the device were pain-free compared with 10 percent in the control group.

The device is not intended for people who have metals in their head, neck or upper body that are attracted by a magnet, or if they have had an active implanted medical device, such as a pacemaker or deep brain stimulator. The Cerena TMS is also not recommended for patients with suspected or diagnosed epilepsy or a personal or family history of seizures.

Source: UPI