(RTTNews) - NuPathe Inc.(PATH) Tuesday reported positive top-line results from a 12 month open-label, safety trial for Zelrix. In addition the company announces the development of an in vitro analytical testing method for Zelrix, as requested by the U.S. Food and Drug Administration or FDA to confirm the amount of sumatriptan delivered.
Zelrix is a single-use, transdermal sumatriptan patch in development for the treatment of migraine.
NuPathe said 183 patients were enrolled and applied at least one Zelrix patch. Significantly, and consistent with findings from the Zelrix Phase III pivotal trial, Zelrix was well tolerated and the incidence of triptan-related adverse events was very low, with only three patients reporting a triptan adverse event with any Zelrix treatment over the course of the 1 year trial.