NuPathe Inc. a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, announced that its New Drug Application (NDA) for Zelrix has been accepted for filing by the US Food and Drug Administration (FDA).

NuPathe submitted the Zelrix NDA on October 29, 2010. The company expects to receive a Prescription Drug User Fee Act (PDUFA) date, the target date for the FDA to complete its review of the NDA, of August 29, 2011. Zelrix is the first ever submission to the FDA of a transdermal patch for the treatment of migraine.

“The FDA's acceptance of our NDA brings us one step closer to providing an attractive treatment option to the millions of underserved migraine patients,” said Jane Hollingsworth, chief executive officer of NuPathe. “By avoiding oral administration and controlling the delivery of sumatriptan with our SmartRelief technology, we believe Zelrix overcomes the limitations of current migraine medications.”

Zelrix is an active, single-use, transdermal sumatriptan patch in development for the treatment of migraine. It is designed to provide migraine patients fast onset and sustained relief through a tolerable, non-oral route of administration and it may provide an attractive treatment option for many migraine patients because it avoids the need for oral administration and does not depend upon gastrointestinal absorption. Many migraine patients delay or avoid treatment with oral migraine medications as a result of underlying nausea and fear of vomiting.

In addition, the reduced gastric motility experienced during migraine may affect the efficacy of oral medications. Zelrix is powered by SmartRelief, NuPathe's proprietary transdermal delivery technology. SmartRelief consists of a controlled delivery technology that uses a mild electrical current to actively transport medication through the skin using a process called iontophoresis.

Migraine is a neurological disorder that affects approximately 31 million adults in the US In addition to a debilitating headache, most migraine patients suffer from one or more significant gastrointestinal problems, including nausea, vomiting and a compromised ability to digest, known as decreased gastric motility. The nausea and vomiting associated with a migraine makes it difficult for many patients to take oral medications, while reduced gastric motility can affect the efficacy of oral medications.

The most prescribed treatments for acute migraine in the US are triptans, accounting for 94% of the 13 million prescriptions filled for acute migraine therapies for the 12 months ending November 2010. Yet, triptan-related adverse events, including chest tightness, chest heaviness, paresthesias, and panic, can lead some patients to avoid or delay treatment with triptans.

NuPathe Inc. is a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders.