NuPathe Submits Zelrix NDA for the Treatment of Migraine

Posted by | November 1, 2010

NuPathe Submits Zelrix NDA for the Treatment of MigraineSafeguard Scientifics’ partner company NuPathe submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The NDA was filed for ZelrixTM, an active, single-use transdermal sumatriptan patch in development for the treatment of migraine. In fact, Zelrix is the first ever submission to the FDA of a transdermal patch for the treatment of migraine.

As NuPathe CEO Jane Hollingsworth stated this morning, “the NDA submission for Zelrix represents a tremendous milestone for NuPathe and the millions of underserved migraine patients.” Migraine affects approximately 28 million adults in the U.S., and 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 (aka decreased gastric motility). The nausea and vomiting associated with migraine often makes it difficult for patients to take oral medications, while reduced gastric motility can affect the efficacy of oral medications.

The team at NuPathe designed Zelrix to overcome the limitations of current migraine treatments by avoiding oral administration and controlling the delivery of medication with the company’s SmartReliefTM transdermal technology.

Zelrix was well-tolerated in both the pivotal Phase III trial and the 12 month open label trial, and to date, in the Phase III clinical development program, Zelrix has been evaluated in approximately 800 patients treated for up to one year.

We congratulate the NuPathe team on their submission to the NDA and applaud their ability to identify an unmet medical need and create a practical point of differentiation within the migraine marketplace. And as a reminder, NuPathe has stated that they plan to launch in the first half of 2012, so there are exciting milestones still to come.

(Visited 119 times, 1 visits today)

Tags: , , , , , , , ,