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 (> or = 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.
RCT Entities:
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 (> or = 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.
Authors: Ayyappa Chaturvedula; Dipty P Joshi; Carter Anderson; Russell L Morris; Walter L Sembrowich; Ajay K Banga Journal: Int J Pharm Date: 2005-06-13 Impact factor: 5.875
Authors: A M Rapoport; W H Visser; N R Cutler; C J Alderton; L A Paulsgrove; R L Davis; M D Ferrari Journal: Neurology Date: 1995-08 Impact factor: 9.910