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Data from the Phase III trial of Zelrix, a transdermal patch under development by NuPathe Inc. for management of acute migraine, showed the patch met the primary efficacy endpoint.
Data from a phase-3 trial investigating a transdermal patch (Zelrix, NuPathe) for the management of acute migraine showed the patch met the primary efficacy end point of improvement in pain freedom for 2 hours post-patch application.
The phase 3 trial involved 530 adults and was performed in a multicenter, randomized, parallel group, double-blind, placebo-controlled trial, comparing Zelrix to placebo.
The patch blends iontophoretic transdermal technology (SmartRelief, NuPathe) with sumatriptan (Imitrex, GlaxoSmithKline).
Other 2-hour efficacy end points were: nausea free (84% for transdermal patch patients, compared with 63% for placebo); photophobia free (51% for transdermal patch vs. 36%, placebo); and phonophobia free (55%, transdermal patch vs. 39%, placebo).
The most common adverse event was application site pain, reported by 23% of patients with the transdermal patch, compared with 15% with placebo. The next most common adverse event was application site tingling, (12%, Zelrix, vs. 19%, placebo).
“The Zelrix patch is a highly-effective, well tolerated, non-oral treatment for migraine,” said Jerome Goldstein, MD, founder of the Headache and Facial Pain Section of the American Academy of Neurology, in a statement.
“Treatment-altering nausea, medication side effects, and inconsistent drug absorption are common problems that prevent many patients from effectively treating their migraines. The data from the clinical trial indicates that Zelrix could benefit many migraine patients,” Dr. Goldstein added.
NuPathe plans to submit an NDA for Zelrix in 2011.