(RTTNews) - NuPathe,Inc.(PATH) Monday said that it completed two Zelrix pharmacokinetic trials and a tolerability trial. Zelrix is a single-use, transdermal sumatriptan patch in development for the treatment of migraine.
The first trial compared the pharmacokinetics of Zelrix in healthy elderly volunteers to healthy young adult volunteers and the pharmacokinetics of Zelrix applied to the upper arm and applied to the thigh. The results demonstrated no clinically significant difference in the pharmacokinetic profile of Zelrix based upon age or application site. Zelrix was well tolerated in the trial with no serious adverse events reported.
The second trial was a confirmatory bioavailability study and the third trial was a safety study that evaluated cumulative skin irritation of Zelrix when applied daily to the same application site. Both trials were successfully completed. The results of all three studies will be used to support our NDA filing for Zelrix.
Jane Hollingsworth, chief executive officer of NuPathe commented, "Given the completion of these studies and the continued progress of our ongoing long-term safety studies, we remain on track to submit our New Drug Application (NDA) for Zelrix to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2010."