Phase 3 study of Zelrix transdermal for the treatment of migraines

NuPathe Inc. announced data from its Phase 3 trial of Zelrix (sumatriptan transdermal patch) for the treatment of acute migraine.  This multi-center, randomized, parallel group, double-blind, placebo-controlled trial compared the efficacy and tolerability of Zelrix to placebo. Zelrix met the primary efficacy endpoint of a statistically significant improvement compared to placebo for pain freedom at two hours after patch application (18 percent vs. 9 percent, p=0.0092). Additional pre-defined two hour efficacy endpoints in patients treated with Zelrix compared to placebo included: pain relief in 53 percent of patients vs. 29 percent (p<0.0001); 84 percent of patients being nausea free vs. 63 percent (p<0.0001); 51 percent of patients being photophobia free vs. 36 percent (p=0.0028); and 55 percent of patients being phonophobia free vs. 39 percent (p=0.0002). In addition to meeting the primary and key secondary endpoints above, in patients treated with Zelrix compared to placebo: 29 percent vs. 19 percent achieved pain relief within one hour (p=0.0135); 71 percent vs. 58 percent were nausea free with one hour (p=0.0251); 34 percent vs. 21 percent achieved sustained pain relief (from 2 to 24 hours) (p=0.0015); and only 40 percent of those patients on Zelrix vs. 60 percent (p<0.0001) of those on placebo required use of a rescue medication.

Zelrix utilizes the SmartRelief transdermal delivery system to deliver sumatriptan, a widely prescribed migraine therapy, in a rapid but controlled manner.  Zelrix is being developed to address limitations with existing migraine therapies such as the difficulty to take oral therapies when patients are nauseated during migraine attacks and side effects associated with peak plasma concentrations that limit patients' ability or willingness to take certain treatments. NuPathe expects to submit an NDA for Zelrix in 2010.

For more information call (484) 567-0130 or visit www.nupathe.com.