(#2) d-Amphetamine Transdermal System in Treatment of Children and Adolescents With ADHD: ADHD-RS-IV Score Analysis From a Pivotal Trial

Abstract: Background: In a pivotal study, the dextroamphetamine transdermal system (d-ATS) met primary and secondary efficacy endpoints for ADHD in children and adolescents. d-ATS efficacy among subgroups was investigated using ADHD-RS-IV total score. Methods: Patients received d-ATS 5mg/9hr, with weekly evaluation for dose increase. Once reached, the optimal dose was maintained throughout the open-label dose-optimization (DOP) and double-blind treatment periods (DBP, Weeks 6/7). Subgroup efficacy in the DBP was assessed by difference (treated vs placebo) in least-squares mean ADHD-RS-IV total score via mixed-model repeated-measures analysis. Subgroups were stratified by age (children [6-12yo], adolescents [13-17yo]), sex, predominant ADHD type (combined, inattentive), baseline ADHD severity by ADHD-RS-IV total score (0-36, 37-54), and optimal dose (10, 15, 20mg/9hr). Week 5 percent change from baseline in ADHD-RS-IV total score was also analyzed. Results: The DOP included 110 patients, with 106 randomized in the DBP. In the DBP, least-squares mean improvements in ADHD-RS-IV total score (treated vs placebo) of ?8 were observed in each subgroup. At DOP Week 5, children and adolescents showed improvements from baseline of 65% and 69%, respectively. Males and females demonstrated improvements of 66% and 67%, respectively; patients with predominately combined-type and inattentive-type ADHD showed improvements of 65% and 67%, respectively; and patients with baseline ADHD-RS-IV scores of 0-36 and 37-54 showed improvements of 67% and 66%, respectively. Score improvements in patients receiving optimized d-ATS doses of 10, 15, and 20mg/9hr were 68%, 63%, and 69%, respectively. Conclusion: d-ATS was effective in treating ADHD in children and adolescents across all investigated subgroups.Short Description: In this post hoc analysis of a pivotal study of the d-amphetamine transdermal system (d-ATS) for ADHD in children/adolescents, improvements of at least 50% from baseline ADHD-RS-IV total score were observed in patients regardless of age group, sex, ADHD type, baseline ADHD severity, or optimal dose. These results indicate that d-ATS was broadly effective in treating ADHD in children and adolescents.Name of Sponsoring Organization(s): Supported by Noven Pharmaceuticals, Inc.