Abstract
Purpose
Migraines affect approximately 10% of the adult population worldwide. The purpose of this study was to assess the pharmacokinetic and safety profile of a novel iontophoretic sumatriptan delivery system, NP101, which uses an electrical current to propel sumatriptan across intact skin and into underlying tissue. Four unique prototype iontophoretic sumatriptan patch conditions were compared to a 6 mg subcutaneous injection and an oral 50 mg tablet of sumatriptan succinate.
Materials and Methods
This was a randomized, single-center, single-dose, six-period Phase I study.
Results
Patches were well tolerated with fewer adverse events than the subcutaneous injection. Adverse events that were more prevalent for NP101 than other formulations included localized sensations and reactions at the patch site. A linear relationship was observed between total applied current and sumatriptan delivery. Patches delivering 6 and 12 mA per h yielded favorable sumatriptan systemic profiles, delivering drug at a rate that maintained plasma levels above the target level (≥10 ng/ml) for greater than 7 h.
Conclusions
This study met the initial objective to define the dose–current relationship in humans as well as delimiting specific current and current density targets for a well tolerated patch design that can deliver therapeutic drug levels for longer periods than currently possible.
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Acknowledgments
This work is sponsored by NuPathe Inc. Carol O’Neill and Terri Sebree are employees of NuPathe. Steven Siegel has received grant support and consulted to NuPathe Inc. Russell Morris is an employee of Travanti Pharma, makers of the WEDD technology used in the sumatriptan delivery system described in this manuscript. David Jackson and Louise Dubé are consultants to NuPathe. Peter Kaldeway, the principal investigator and study physician, is an employee of the Kendle International Clinical Pharmacology Unit and has no financial relationship with NuPathe or its subsidiaries.
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Siegel, S.J., O’Neill, C., Dubé, L.M. et al. A Unique Iontophoretic Patch for Optimal Transdermal Delivery of Sumatriptan. Pharm Res 24, 1919–1926 (2007). https://doi.org/10.1007/s11095-007-9317-1
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DOI: https://doi.org/10.1007/s11095-007-9317-1