NuPathe Initiates Dosing Of Patients In Phase 1 Study Of ZECUITY - Quick Facts

(RTTNews) - NuPathe Inc. (PATH) announced the company has initiated dosing of patients for NP101-015, a Phase 1 study of ZECUITY in adolescents with a history of migraine attacks. The open label, single-dose study will assess the safety, pharmacokinetics, and tolerability of ZECUITY in adolescent migraine patients. The study is part of the company's post-marketing requirements.

ZECUITY was approved by the U.S. FDA in January 2013 for the acute treatment of migraine with or without aura in adults and is the first and only FDA-approved patch for the treatment of migraine.

The primary objectives of the study are to: determine the safety and tolerability of a single dose of ZECUITY in adolescent subjects with a history of acute migraine; and to determine the pharmacokinetics of sumatriptan in adolescent subjects when delivered by ZECUITY's transdermal route of administration. Results are expected in July 2014.