Putting a patch on migraines
There’s new hope for the more than 30 million Americans who suffer from migraines, thanks to a new method of delivering a widely-prescribed drug through a transdermal system in the form of a patch.
"Although consumers are familiar with using a patch for, say, smoking cessation, this is the first patch FDA has approved to treat migraines," says neurologist Eric Bastings, M.D., deputy director of the Division of Neurology at the Food and Drug Administration (FDA).
Bastings says there are still practical measures you can take to prevent painful migraines, including FDA-approved medications that either stave off their onset or relieve their pain. He also says there are two basic kinds of migraine medications: 1) abortive (or acute) medications that treat migraines after they begin; and 2) preventive medications that help keep migraines from developing in the first place.
In January 2013, the FDA approved the use of sumatriptan, branded as Imitrex, through a new mechanism in the form of a patch that can be wrapped around a patient's upper arm or thigh, where the medication is absorbed through the skin. To learn more about the new FDA-approved patch, click here.
The patch provides an alternative to pills, nasal sprays and injections. For migraine patients who experience debilitating pain, Bastings said that the patch can be particularly useful because the pain can sometimes be so acute that such patients can’t even swallow a pill.
So how does the patch work?
The patch, which is named Zecuity, is battery-powered and is approximately 8 inches long and 4 inches wide. It wraps around the arm or thigh in a manner similar to an ace bandage, using an electrical current to move the drug through the skin over the course of four hours. According to Bastings, a small battery and computer chip regulate the charge to make sure the patient receives the correct dosage.
Bastings pointed out that this new delivery system is especially helpful for patients who don't like the unpleasant after-taste sometimes associated with nasal sprays, as well as for patients who don’t feel comfortable injecting themselves.
Nevertheless, Bastings acknowledges that the patch does have some drawbacks. Due to its relatively large size, for example, it can be seen when wearing short-sleeved shirts or shorts. Unlike a nasal spray or taking a migraine pill, the patch also requires some privacy if the patient needs to undress in order to put it on.
"For many people, popping a pill is a lot more immediate and simple," Bastings says.
Indeed, approximately 25 percent of participants in the clinical study complained that they felt a painful sensation at the site where the patch was applied, while other participants complained that they developed redness at the application site after using the patch.
What causes a migraine in the first place?
Over 30 million Americans, which is approximately 12 percent of the U.S. population, suffers from migraines, according to the National Institutes of Health (NIH). Children and adults experience them, although they affect adult women three times more often than men.
Bastings describes migraines as neurovascular headaches that are characterized by throbbing and pulsating pain caused by the a temporary widening of blood vessels in the brain, which is triggered by abnormal activation of nerve pathways involved in the transmission of pain signals.
According to the FDA, characteristics of a migraine frequently include the following:
• Pain typically on one side of the head
• Pain that has a pulsating or throbbing quality
• Moderate to intense pain that affects daily activities
• Nausea or vomiting
• Sensitivity to light or sound
• Aura, visual disturbances that signal the beginning, such as dots, flashing lights or blind spots
Bastings also points out that a number of studies have found migraines are often underdiagnosed by both patients and physicians.
"Many people don't recognize the symptoms as belonging to migraine," he says. “Or they don't think of sharing information about the occasional headache with their physician, even if it is severe.”
What are some FDA-approved drugs for treating acute migraine?
There are a number of drugs approved by the FDA for treating acute migraine, including the triptans, such as Imitrex, which bind to serotonin receptors in the brain nerve fibers and blood vessels. According to the FDA’s website on migraines, serotonin acts as a neurotransmitter, which is a type of chemical that helps relay signals from one area of the brain to another.
There are also non-prescription, "over the counter" drugs that can help, such as ibuprofen, aspirin and acetaminophen.
"These abortive medications work most effectively if taken early in the attack," says Bastings.
Those suffering frequent or severe migraines may also benefit from prescription preventive medications, including beta-blockers, a type of blood pressure drug (such as metoprolol). Other prescribed medications that can help are certain antiepileptic drugs (such as topiramate and divalproex sodium), according to the FDA.
Interestingly, the agency also approved Botox in October 2010 for treating chronic migraines at least 15 days a month.
In the meantime, Bastings offers another way to prevent migraines that involves learning your personal "triggers" that bring on the headache. Common triggers include the following:
• Hormonal changes in women, with migraines frequently occurring around the menstrual cycle;
• Certain foods and beverages, such as alcoholic and caffeinated drinks, chocolate and aged cheeses;
• Stress; and
• Changes in waking and sleeping patterns.
"It certainly can help to know your triggers and avoid them when possible," Bastings says. "Of course if a major trigger is stress, few of us can entirely avoid that in our lives."
SOURCE: FDA's Consumer Updates (March 21, 2013); National Institutes of Health