NuPathe Inc., a specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases, today announced data from the pivotal Phase III trial of Zelrix™, a novel transdermal patch in clinical development for the treatment of acute migraine. Zelrix combines NuPathe’s proprietary SmartRelief™ iontophoretic transdermal technology with sumatriptan, the most prescribed treatment for acute migraine in the United States. The Phase III trial was conducted in 530 adults and was administered in a multi-center, randomized, parallel group, double-blind, placebo-controlled trial, where efficacy and tolerability of Zelrix were compared with 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,>
- Pain relief: 53 percent of patients treated with Zelrix compared with 29 percent for placebo (p<0.0001);
- Nausea free: 84 percent of patients treated with Zelrix compared with 63 percent for placebo (p<0.0001);
- Photophobia free: 51 percent of patients treated with Zelrix compared with 36 percent for placebo>
- Phonophobia free: 55 percent of patients treated with Zelrix compared with 39 percent for placebo>
In addition to meeting the primary and key secondary endpoints, Zelrix demonstrated rapid efficacy and sustained pain relief with lower use of rescue medication: