NuPathe has recently concluded two pharmacokinetic trials and a tolerability trial of Zelrix, a single-use, transdermal sumatriptan patch in development for the treatment of migraine.
NuPathe said that 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.
Reportedly, the results demonstrated no clinically significant difference in the pharmacokinetic profile of Zelrix based upon age or application site and additionally, Zelrix was well tolerated in the trial.
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, which were also successfully completed.
NuPathe CEO Jane Hollingsworth said that given the completion of these studies and the continued progress of the ongoing long-term safety studies, they remain on track to submit the new drug application (NDA) for Zelrix to the US Food and Drug Administration in the fourth quarter of 2010.
NuPathe chief scientific officer Mark Pierce said that Zelrix was designed specifically to overcome the limitations of current migraine therapies by providing rapid and controlled delivery of sumatriptan while bypassing the need for oral administration and reliance on gastrointestinal absorption.