More Ways to Fight Migraine Pain: An FDA Update

Thought there was no hope for treating your migraine headaches? Don’t give up.

In the past year, the Food and Drug Administration (FDA) has given adults new options for treating migraines by allowing the marketing of two prescription devices for such headaches. People who don’t tolerate drug treatments well might find relief by using the Cerena Transcranial Magnetic Stimulator or the Cefaly transcutaneous electrical nerve stimulation device. Both devices have been shown in clinical studies to be effective and pose minimal risks and side effects when used according to their labeling.

There’s a great need for these noninvasive devices because many anti-migraine drugs have side effects that some patients can’t tolerate, says Michael Hoffmann, a biomedical engineer with FDA.

“A drug may have the potential for systemic side effects because it’s ingested and metabolized. It may also have a variety of side effects that vary from person to person,” Hoffmann explains. “Patients have been looking for alternative migraine treatments. Because these devices aren’t ingested or metabolized like drug therapies, they don’t necessarily have the same types of side effects.”

Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head accompanied by nausea and/or vomiting and sensitivity to light and sound. A migraine can last four to 72 hours when untreated. According to the National Institutes of Health (NIH), 12 percent of Americans (about 37 million people) have migraines. These debilitating headaches affect children and adults, and women are three times more likely to have migraines than men (about 18 percent of women have migraines).

About one-third of people with migraines experience an aura—visual disturbances such as dots, flashing lights or a blind spot—that signals the beginning of the headache. Cerena is the first medical device granted marketing by FDA to relieve pain caused by migraine headaches that are preceded by an aura.

Patients use Cerena when they feel a headache coming on or when the pain begins. Using both hands to hold the device against the back of the head, the patient presses a button to release a very short (less than one second) magnetic pulse to stimulate the brain’s occipital cortex (the back part of the brain that processes visual information). Transcranial Magnetic Stimulator (TMS) technology, used in the Cerena device, has been studied for quite some time but has only recently been authorized for specific clinical uses.