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FDA Accepts NuPathe's Migraine Patch NDA Resubmission for Filing
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Nupathe Inc. (MM) (NASDAQ:PATH)
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Today : Tuesday 31 July 2012


NuPathe Inc. (NASDAQ: PATH), a biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced that the company's New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the U.S. Food and Drug Administration (FDA). NuPathe has received a Prescription Drug User Fee Act (PDUFA) date, the target date for the FDA to complete its review of the NDA, of January 17, 2013.
"As important as FDA acceptance of our NDA resubmission is for NuPathe, we believe it's even more significant for the millions of migraine patients who suffer from headache pain and debilitating migraine-related nausea," said Armando Anido, chief executive officer of NuPathe. "We look forward to working closely with the FDA to complete its review and to bringing our innovative new treatment option to migraine patients in 2013."

About the Migraine Patch (NP101 or Zelrix)

NP101 is an active, single-use, transdermal patch in development for the treatment of migraine. If approved, it will be the first transdermal patch for the treatment of migraine. The patch actively delivers sumatriptan, the most widely prescribed migraine medication. In three clinical trials involving more than 10,000 applications, NP101 offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). Because NP101 delivers sumatriptan transdermally, it may be an attractive treatment option for many frequent MRN sufferers and those patients who experience gastroparesis, a slowing of gastric absorption. The patch utilizes SmartRelief™, NuPathe's proprietary transdermal delivery technology that allows the rapid yet tightly controlled transport of medication through the skin using a process called iontophoresis. As a result, in NP101 clinical trials there was a low incidence of triptan sensations that include chest tightness, flushing and feelings of pressure and numbness.

About Migraine and Migraine-Related Nausea

Migraine is a neurological disorder that affects approximately 30 million adults in the U.S. In addition to a headache pain, most migraine patients suffer from one or more significant gastrointestinal problems, including nausea, vomiting, and gastroparesis. Approximately eight million diagnosed migraine sufferers experience MRN in greater than fifty percent of their migraines. These frequent-MRN sufferers are less likely to achieve headache relief with oral triptans and are less satisfied with their current migraine medications. They experience more medication-related interference in several aspects of life, including their ability to work and spend time with family. In addition, these patients generate increased direct medical costs as a result of their five-fold increase in emergency room and urgent care visits and eight-fold increase in overnight hospital stay costs. Some migraine patients also experience gastroparesis, which may affect a patient's response to oral medications.