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FDA Approves Acute Migraine Treatment Patch System

Migraine (Sasha Wolff/Flickr)The U.S. Food and Drug Administration approved a battery-powered patch system made by Nupathe Inc. of Conshohocken, Pennsylvania for the treatment of migraine. The patch, marketed as Zecuity, is a single-use system that delivers the drug sumatriptan, and was approved by FDA for treating migraine headaches and nausea after symptoms occur, known as acute treatments.

Migraine headaches cause intense, debilitating throbbing or pulsing in the head for hours or days, and are often coupled with nausea and sensitivity to light and sound. In some cases, sensory warning symptoms called aura, such as flashes of light, blind spots or tingling in arms or legs precede or accompany migraines. NuPathe says Zecuity patches can treat migraines with or without aura.

Sumatriptan, approved in the U.S. for treating migraines since 1992, relieves migraines by stimulating serotonin receptors in the brain — serotonin is a neuro-signaling hormone — which cause the muscles surrounding the blood vessels in the brain to contract and narrow the blood vessels. Sumatriptan also reduces transmission of pain signals by nerves to the brain.

Zecuity is applied to the upper arm or thigh during a migraine that delivers 6.5 milligrams of sumatriptan through the skin, bypassing the gastrointestinal tract. During the four-hour dosing period, a microprocessor monitors skin resistance and adjusts drug the delivery accordingly. Zecuity comes with a list of safety restrictions, including recommendations against its use for patients with heart disease, stroke, peripheral vascular disease, uncontrolled blood pressure, or problems with blood circulation. The most common side effects are application site pain, tingling, itching, warmth, and discomfort, as well as skin redness after its removal.

FDA approved the system after phase 3 clinical trials with more than 700 patients. In those trials, twice as many patients treated with Zecuity achieved freedom from headache pain at two hours compared to a placebo. More than half of patients (53%) treated with Zecuity had relief from headache pain and a large majority (84%) were free of nausea after two hours.

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Hat tip: MedCity News

Photo: Sasha Wolff/Flickr

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