NuPathe, Inc., a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, announced on November 1 that they have submitted a New Drug Application (NDA) for Zelrix™ to the U.S. Food and Drug Administration (FDA). An NDA is the application made to request that the FDA approve a medication. Zelrix is the first submission to the FDA of a transdermal patch for the treatment of Migraine.

Jane Hollingsworth, chief executive officer of NuPathe, commented:

"The NDA submission for Zelrix represents a tremendous milestone for the company and the millions of underserved migraine patients. The dedication and persistence of our employees allowed us to develop this truly novel solution and achieve our goal of submitting the NDA prior to year end."

Mark Pierce, MD, PhD, chief scientific officer of NuPathe, said:

"We designed Zelrix specifically to overcome the limitations of current treatments by avoiding oral administration and controlling the delivery of medication with our SmartRelief™ transdermal technology. Results from the clinical development program demonstrate efficacy and a favorable tolerability profile for Zelrix in both our single migraine pivotal trial and our long-term open label trial, during which patients used Zelrix over a 12 month period."

SmartRelief™ is NuPathe's proprietary transdermal medication delivery technology based on iontophoresis, a noninvasive method of actively transporting molecules, such as sumatriptan, that are not able to be delivered passively through the skin. Iontophoresis involves the application of a mild electrical current to the skin through two reservoirs. One reservoir contains ionized, or charged, medication. The other reservoir contains a counter ion, commonly sodium chloride, or salt. When a current is applied, medication molecules travel out of the reservoir into the skin, where blood vessels absorb and disburse them throughout the body. Unlike passive transdermal technologies, which rely on diffusion for medication delivery, iontophoresis controls the amount and rate of medication delivery. Iontophoresis enables transdermal delivery of a variety of medications that cannot be delivered passively through the skin. It is possible to deliver a variety of different medications, including proteins and peptides, using iontophoresis.

The Zelrix patch has a better chance of working for some Migraineurs because it doesn't have to pass through the digestive system. Clinical trials showed fewer side effects with this sumatriptan patch than with oral sumatriptan. Since this is a different way of delivering sumatriptan, and sumatriptan has been FDA approved and in use for so long, maybe FDA approval won't take as long as it would if it were a totally new medication. We shall see.

For more information about Zelrix, see New Zelrix Patch for Migraine. For more about the FDA approval process, see Migraine Drugs: From Clinical Trial to Drug Approval.