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FDA Approves First Device to Relieve Migraine Pain
The FDA has approved the Cerena Transcranial Magnetic Stimulator (TMS) (eNeura Therapeutics), the first device to relieve pain caused by migraine headaches that are preceded by an aura (a visual, sensory, or motor disturbance immediately preceding the onset of a migraine attack).
Migraine headaches are three times more common in women than in men. About one third of people with migraines experience an aura.
The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. Using both hands to hold the device against the back of the head, the user presses a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain, which may stop or lessen the pain associated with migraine headaches preceded by an aura.
The FDA reviewed a randomized controlled clinical trial involving 201 patients who had mostly moderate-to-strong migraine headaches, with auras preceding at least 30% of their migraines. Of the study subjects, 113 recorded treating a migraine at least once when pain was present. An analysis of these 113 patients was used to support marketing authorization for Cerena TMS for the acute treatment of pain associated with migraine headache with aura.
The study showed that nearly 38% of patients who used the Cerena TMS when they had migraine pain were pain-free 2 hours after using the device compared with about 17% of patients in the control group. After 24 hours, nearly 34% of the Cerena TMS users were pain-free compared with 10% of the control group.
The study did not show that the Cerena TMS is effective in relieving the associated symptoms of migraine, such as sensitivity to light, sensitivity to sound, and nausea. The device is for use in patients 18 years of age and older. The study did not evaluate the device’s performance when treating types of headaches other than migraine headaches preceded by an aura.
Source: FDA; December 15, 2013.