We previously reported on a positive Phase I study of a novel way of taking sumatriptan: Zelrix® would deliver the active ingredient in Imitrex® through the skin via a transdermal patch. Now the results of a Phase III trial involving 530 patients are in. According to NuPathe, which is developing Zelrix, the trial showed “statistically significant improvement” in pain relief, absence of nausea and three other endpoints two hours after the patch was applied as compared to a placebo patch.
The patch, which was designed for migraineurs who experience nausea, allows sumatriptan to take effect without having to go through the gastrointestinal system.
A comprehensive summary of the data will be presented at the 14th Congress of the International Headache Society starting on Sept. 10. NuPathe plans to file a new drug application with the US Food and Drug Administration in 2010.