Source - RTT

(RTTNews) - Pharmaceutical company NuPathe Inc. (PATH) announced on Monday that the company submitted a New Drug Application, or NDA, for Zelrix to the U.S. Food and Drug Administration, or FDA. Zelrix is an active, single-use, transdermal sumatriptan patch in development for the treatment of migraine.

The NDA submission is based on a comprehensive development program, including data from a pivotal Phase III trial conducted in 530 migraine patients, where the efficacy and tolerability of Zelrix were compared with a matching placebo patch. Zelrix was well-tolerated in both the pivotal Phase III trial and the 12-month long-term open label trial.