Zosano Pharma Completes Enrollment in Phase 1 Study for Microneedle Patch Delivery of Zolmitriptan for the Treatment of Migraine

Zosano Pharma Corporation

, a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver therapeutics conveniently through the skin for the treatment of a variety of indications, announced today that it has completed enrollment in a Phase 1 clinical study for a novel method for delivering treatments for migraine headaches. The crossover study among 20 healthy volunteers will test the tolerability and pharmacokinetics of up to five doses of ZP-Triptan compared to subcutaneous injection of sumatriptan and oral administration of zolmitriptan. ZP-Triptan is a zolmitriptan-coated microneedle patch that is applied to an individual's upper arm to deliver zolmitriptan to the body. ZP-Triptan has the potential to demonstrate rapid onset comparable to subcutaneous administration with the injection-free and ease-of-use characteristics of Zosano's microneedle patch and applicator system. "The ZP-Triptan program is an important component of Zosano's clinical portfolio," said Zosano's Chief Medical Officer Thorsten von Stein, M.D., Ph.D. "We've reached a critical milestone with the completion of enrollment in the Phase 1 clinical study. We anticipate having data by the end of 2015." During Part 1 of the study, the 20 participants will be randomized and receive the following treatments: a 0.48 mg ZP-Triptan patch, two 0.48 mg ZP-Triptan patches, a 1.9 mg ZP-Triptan patch, a 2.5 mg oral zolmitriptan tablet, and a subcutaneous injection of sumatriptan, a common treatment for migraine headaches. Part 2 and Part 3 of the study will be higher dose tolerability studies, testing two 1.9 mg ZP-Triptan patches and a 3.8 mg ZP-Triptan patch. The study is designed to examine time to onset, bioavailability and safety and tolerability for the microneedle patch doses compared to commercially available products.