The study was a randomized, single-center, single-dose, six-period pilot study to evaluate four SmartRelief prototypes. The study compared sumatriptan pharmacokinetics and safety following administration of NP101 SmartRelief prototype patches with GlaxoSmithKline’s Imitrex 50mg tablets, and Imitrex 6mg subcutaneous injection.
In the study, NP101 maintained continual therapeutic dosing levels of sumatriptan an average of four times longer than treatment with the 6mg injection of Imitrex and up to twice as long as treatment with the 50mg tablet of Imitrex. NP101 was also generally well tolerated.
Jane Hollingsworth, CEO of NuPathe, said: “Patients need better options for treatment of acute migraine attacks. Triptans, which are considered the gold standard in treatment today, are proven to be efficacious, but they often result in inconsistent response, nausea, and recurrent headaches. Through NuPathe’s patented transdermal delivery system, NP101 is designed to deliver sumatriptan in a consistent and sustained manner through a patch, significantly reducing the risk of GI problems.”