FDA Approves Transdermal Patch for Migraine

Laurie Barclay, MD

January 18, 2013

The U.S. Food and Drug Administration (FDA) has approved sumatriptan iontophoretic transdermal system (Zecuity, NuPathe Inc) for acute treatment of adults who have migraine with or without aura. The single-use, battery-powered patch offers relief of migraine-related nausea (MRN) as well as migraine headache pain.

Of 16 million U.S. adults diagnosed and treated with migraine, 8 million have MRN and typically avoid use of oral medications.

"In addition to severe headache pain, migraine patients present with other significant symptoms, which commonly includes [MRN]," Lawrence C. Newman, MD, director of the Headache Institute at St. Luke's-Roosevelt Hospital in New York City, said in a news release from the company. "For these patients, physicians need to assess and offer treatments tailored to each individual patient's array of migraine symptoms. In fact, the American Academy of Neurology guidelines recommend a non-oral route of administration for migraineurs who experience nausea or vomiting as significant symptoms."

When applied to the upper arm or thigh during a migraine and activated with a push button, the patch initiates transdermal delivery of sumatriptan, bypassing the gastrointestinal (GI) tract. Using a microprocessor to continuously monitor skin resistance, the patch delivers a total dose of 6.5 mg throughout the 4-hour dosing period.

In phase 3 trials enrolling a total of 800 patients with migraine who used more than 10,000 patches, the treatment safely and effectively relieved migraine pain, MRN, sonophobia, and photophobia within 2 hours of patch activation.

Headache pain resolved at 2 hours in 18% of patients receiving the active patch in the phase 3 pivotal study, compared with 9% of those receiving placebo. At 2 hours, headache pain relief occurred in 53% of treated patients and in 29% of those receiving placebo. Freedom from nausea at 2 hours occurred in 84% and in 63%, respectively.

"[MRN] can be as debilitating as migraine headache pain itself," said study investigator Stephen D. Silberstein, MD, professor of neurology and director of the Jefferson Headache Center in Philadelphia, Pennsylvania. "Treatments bypassing the GI tract may be the best way to treat these patients."

The most commonly reported adverse effects associated with the patch, occurring in more than 5% of patients, were application site pain, tingling, itching, warmth, and discomfort. Adverse events often associated with triptans include atypical sensations, which occurred in 2% of patients receiving treatment, and pain and other pressure sensations, also reported in 2%.

Contraindications to use of Zecuity (formerly known as NP101 and Zelrix) are history of coronary artery disease or coronary vasospasm; Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders; history of stroke, transient ischemic attack, or hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; use of another triptan or an ergotamine within 24 hours; use of a monoamine oxidase A inhibitor in the past 2 weeks; hypersensitivity to sumatriptan or components of Zecuity; severe hepatic impairment; and allergic contact dermatitis to the product. Use during an MRI is also contraindicated.

Like other triptans, Zecuity may be associated with potentially life-threatening serotonin syndrome.