NuPathe’s Patch for Migraine Wins FDA Approval

Adults with migraine will soon have a new treatment option — Zecuity, a transdermal, battery-powered sumatriptan patch.

NuPathe, maker of the patch, said the FDA has approved the single-use patch to treat headache pain and nausea caused by migraine, with or without aura.

The patch is applied to the upper arm or thigh during a migraine and can deliver 6.5 mg of sumatriptan over the course of 4 hours once activated by push button.

The treatment system was approved based on the results of a phase III, placebo-controlled trial of 800 patients that showed the sumatriptan delivery method was safe and effective, the drugmaker said in a statement.

The FDA failed to approve a NuPathe application for a transdermal sumatriptan patch called Zelrix in August 2011.

In a complete response letter, the agency asked the company for additional data on Zelrix, citing concerns over the patch’s safety, chemistry, and manufacturing. The FDA’s approval of Zecuity may obviate the need for those additional studies.

The device is contraindicated in patients with heart disease, a history of heart disease or stroke, peripheral vascular disease, transient ischemic attack, blood circulation problems, uncontrolled blood pressure, basilar migraines, contraindication to sumatriptan or parts of the device, or Wolff-Parkinson-White syndrome or similar heart rhythm disturbances.

The system should not be used if taken within 24 hours of using another migraine medication or within 2 weeks of using a monoamine oxidase-A inhibitor.

Triptans, such as sumatriptan, can cause serotonin syndrome, which can be exacerbated when used with certain antidepressants.

Patients with heart disease, a family history of heart disease, stroke, high cholesterol or diabetes, have gone through menopause, who smoke, have had epilepsy or seizures, or are pregnant, nursing, or thinking about becoming a parent should consult a healthcare professional before using Zecuity.

(Image: Corbis)