NuPathe files NDA for transdermal delivery of migraine meds

With 28 million Americans suffering from migraines--according to Pennsylvania company NuPathe--there would be an awful lot of grateful people if a company comes up with a quick, efficient way of offering relief to the suffering masses. There many possible solutions, including this one we featured a couple of weeks ago, but NuPathe has the first migraine relief candidate that comes in a transdermal patch. The company announced Monday that it has submitted new drug application to the FDA for Zelrix, a patch that contains sumatriptan.

Nupathe's proprietary transdermal delivery technology, called SmartRelief, uses a mild electrical current to actively deliver sumatriptan, which is an already approved migraine drug, through the skin in a process called iontophoresis. Zelrix was designed to overcome several of the key limitations associated with current migraine treatments, including nausea, poor or inconsistent relief and fear of adverse events like chest tightness or numbness in the extremities, according to the company.

"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," Mark Pierce, NuPathe's chief scientific officer, says in a prepared statement. "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."

- read the NuPathe release
- and a brief report in the Philadelphia Business Journal
- and here's the technology described by NuPathe