Skin Patch for Migraines Receives FDA Approval
Zecuity is a battery-powered skin patch that delivers sumatriptan through the patientâ€™s skin â€“ it is a single-use medication.
Sumatriptan is the most extensively prescribed migraine drug. According to NuPathe Inc., the makers and marketers of Zecuity, the patch is effective in treating migraine headache pain as well as migraine-related nausea.
Armando Anido, CEO of NuPathe, said, â€œThe approval of Zecuity represents a major milestone for NuPathe and migraine sufferers. As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea.â€
â€œWe thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year.â€
Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache Institute at St. Lukeâ€™s-Roosevelt Hospital, New York, explained that apart from painful headaches, people with migraine often have other symptoms, including nausea (migraine-related nausea, or MRN). For these other symptoms, doctors need to assess each individual patient and offer tailored treatments.
According to the American Academy of Neurology, migraine patients who have nausea symptoms should not take medications via the mouth (oral route), because of the risk of vomiting.
Study researcher, Stephen D. Silberstein, MD, FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache Center in Philadelphia, said that migraine-related nausea can be as incapacitating as a migraine headache. Treatments for such patients should bypass the gastrointestinal tract, he added.
An analysis of the National Headache Foundationâ€™s landmark American Migraine Prevalence and Prevention (AMPP) Study in 2011 found that migraine with nausea is significantly debilitating.
Zecuity migraine patch is both safe and effective in human trials
The FDA examined the findings from Phase III trials involving over 800 patients and more than 10,000 Zecuity skin patches. The studies showed that Zecuity is both safe and effective in the treatment of migraine as well as relieving its cardinal symptoms, which include severe headache, migraine-related nausea, photophobia and sensitivity to sound, within two hours of placing the patch on the skin.
A Phase III pivotal study showed that:
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