NuPathe Reports Positive Phase III Results For Zelrix

NuPathe has reported the top-line results from the pivotal phase III clinical trial of Zelrix, a novel transdermal patch in clinical development, for the treatment of acute migraine.

In the multi-center, randomized, parallel group, double-blind, placebo-controlled trial, the efficacy and tolerability of Zelrix were compared with placebo in a total of 530 adults.

Results demonstrated improvement for patients two hours after applying the Zelrix patch, as compared to patients applying a placebo patch, for each of the five key efficacy endpoints: pain free, pain relief, nausea free, photophobia free and phonophobia free.

Zelrix was well-tolerated in the trial, said the company. Skin tolerability was typical of other transdermal products with mild-to-moderate erythema present upon patch removal. The incidence of triptan-specific adverse events was very low.

Mark Pierce, chief scientific officer at NuPathe, said: “The pivotal Phase III results confirm that Zelrix provides clear clinical benefits for patients. Zelrix demonstrated efficacy consistently across all symptoms of acute migraine combined with a very low incidence of triptan adverse events.

“Patients need a migraine treatment that can deliver effective relief in a well-tolerated manner without being undermined by the treatment-altering nausea, vomiting, or other gastric symptoms associated with migraine. This milestone brings NuPathe one step closer to bringing the first and only migraine patch to the market. We look forward to submitting an NDA for Zelrix in 2010,” he added.