July 1, 2008
NuPathe Announces Encouraging Results From Phase I Migraine Trial
NuPathe has reported positive Phase I results for NP101, a novel drug-device patch for acute migraine in clinical development.
NuPathe's NP101 combines its SmartRelief proprietary iontophoretic transdermal technology with sumatriptan, the most widely prescribed treatment for acute migraine in the US and the active ingredient in Imitrex.
The study was a Phase I, single center, single-dose, open label, five-way crossover study to compare the pharmacokinetics of two NP101 patch formulations with three FDA approved formulations of Imitrex (20mg nasal spray, 100mg oral tablet, 6mg subcutaneous injection) in 23 healthy volunteers.
Tolerability and safety were assessed for all formulations and skin evaluations were performed for subjects after administration of NP101. The plasma concentrations for NP101 were more consistent among subjects compared to either the 20mg nasal spray or 100mg oral tablet formulations. NP101 was well tolerated.
Mark Pierce, chief scientific officer of NuPathe, said: "These findings support the hypothesis that parenteral administration of sumatriptan, either through subcutaneous injection or transdermal delivery, provides a more predictable method of drug delivery by bypassing absorption through the gastrointestinal system."