Noven Pharmaceuticals, a a specialty pharmaceutical company and wholly-owned subsidiary of Hisamitsu Pharmaceutical, has commenced a phase II study of a d-Amphetamine Transdermal System (d-ATS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.
Currently, there is no approved amphetamine-based transdermal treatment option available for ADHD. The trial is a randomized, double-blind, placebo-controlled, crossover study designed to evaluate the safety and efficacy of d-ATS compared to placebo in subjects between six and 17 years of age. The study is expected to enroll approximately 90 subjects at up to five study sites and is scheduled to conclude in the second quarter of 2013.
Additional information on the phase II study will be made available on ClinicalTrials.gov.