NuPathe Inc, announced the results from the pivotal Phase III clinical trial of Zelrix, a novel transdermal patch in clinical development for the treatment of acute migraine. In this 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.
The Zelrix patch combines NuPathe’s SmartRelief iontophoretic transdermal technology with sumatriptan, the most prescribed treatment for acute migraine in the United States. “Zelrix was designed to overcome key barriers to successful treatment of migraine: treatment-altering nausea, treatment-limiting side effects, and inconsistent drug absorption,” said Jane Hollingsworth, chief executive officer of NuPathe.
Results of the pivotal Phase III clinical study demonstrated statistically significant improvement for patients two hours after applying the Zelrix patch compared to patients applying a placebo patch for each of the five key efficacy endpoints that include pain free (pain symptom score = 0), pain relief, nausea free, photophobia free,phonophobia free.
Zelrix was well-tolerated in the trial. 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. The most common adverse events were itching, pain, and tingling at the application site. The majority of adverse events were reported as mild and transient.
“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,” said Mark Pierce, M.D., Ph.D., chief scientific officer at NuPathe. “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.”