Tuesday, July 23, 2013

Noven announce positive Phase 2 results of Investigational d-amphetamine Transdermal system

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced top-line results from its Phase 2 clinical study evaluating d-Amphetamine Transdermal System (d-ATS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Currently, there is no amphetamine-based transdermal treatment option available for ADHD.

The Phase 2 study was a randomized, double-blind, placebo-controlled, crossover, laboratory classroom study to evaluate the safety and efficacy of d-ATS compared to placebo in subjects 6 to 17 years of age.
The 7-week study enrolled 110 patients. The primary outcome measure in the study was mean total SKAMP score for d-ATS compared to placebo. The SKAMP scale measures manifestations of ADHD symptoms using an independent observer (teacher) rating of the child's impairment in classroom behavior. The Phase 2 study achieved the primary endpoint with statistical significance, and no serious adverse events were reported



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