Poster
131
(#131) d-Amphetamine Transdermal System in Treatment of Children and Adolescents with ADHD: Analysis of Conners' Parent Rating Scale-Revised Short Form Subscale Scores From a Pivotal Trial
Psych Congress 2025
Abstract: Background: d-ATS is the only amphetamine-based transdermal treatment available for ADHD. Compared to oral drugs, transdermal formulations allow for greater individualized tailoring of medication effects. CPRS-R:S is a standard scale used to assess ADHD behaviors in children and adolescents based on parent/caregiver observations. In a pivotal study, d-ATS demonstrated significant improvement in CPRS-R:S total score. Here, d-ATS efficacy is reported using CPRS-R:S subscale scores that further investigate its impact across multiple behaviors.
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, Weeks 1-5) and double-blind treatment periods (DBP, Weeks 6/7). Efficacy was assessed during the DBP by difference (treated vs placebo) in least-squares (LS) mean change from baseline in CPRS-R:S subscale scores (oppositional, cognitive problems/inattention, hyperactivity, ADHD index) via a likelihood-based mixed-effect model for repeated measures.
Results: The DOP included 110 patients, with 106 randomized in the DBP. In the DBP, the differences in LS mean (95% CI) CPRS-R:S oppositional, cognitive problems/inattention, hyperactivity, and ADHD index scores for d-ATS vs placebo were -2.4 (-3.8, -1.1); -4.5 (-5.8, -3.2); -3.5 (-4.8, -2.2); and -7.9 (-10.1, -5.6), respectively (all groups P.001). Effect sizes were -0.49, -0.98, -0.76, and -0.97, respectively.
Conclusion: A significant difference between placebo and d-ATS (optimized dose) in each CPRS-R:S subscale score was observed, suggesting that from the parent/caregiver perspective, d-ATS was efficacious in treating ADHD across a spectrum of disruptive behaviors. These findings also add information regarding the impact of d-ATS in multiple settings.
Short Description: In this analysis of a pivotal study of the d-amphetamine transdermal system (d-ATS) for ADHD in children and adolescents, a significant difference between placebo and the optimized dose of d-ATS in each of the parent-rated CPRS-R:S subscale scores (oppositional, cognitive problems/inattention, hyperactivity, and ADHD index) was observed. These results indicate that d-ATS was effective in treating ADHD across a spectrum of disruptive behaviors in children and adolescents.
Name of Sponsoring Organization(s): Noven Pharmaceuticals, Inc.
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, Weeks 1-5) and double-blind treatment periods (DBP, Weeks 6/7). Efficacy was assessed during the DBP by difference (treated vs placebo) in least-squares (LS) mean change from baseline in CPRS-R:S subscale scores (oppositional, cognitive problems/inattention, hyperactivity, ADHD index) via a likelihood-based mixed-effect model for repeated measures.
Results: The DOP included 110 patients, with 106 randomized in the DBP. In the DBP, the differences in LS mean (95% CI) CPRS-R:S oppositional, cognitive problems/inattention, hyperactivity, and ADHD index scores for d-ATS vs placebo were -2.4 (-3.8, -1.1); -4.5 (-5.8, -3.2); -3.5 (-4.8, -2.2); and -7.9 (-10.1, -5.6), respectively (all groups P.001). Effect sizes were -0.49, -0.98, -0.76, and -0.97, respectively.
Conclusion: A significant difference between placebo and d-ATS (optimized dose) in each CPRS-R:S subscale score was observed, suggesting that from the parent/caregiver perspective, d-ATS was efficacious in treating ADHD across a spectrum of disruptive behaviors. These findings also add information regarding the impact of d-ATS in multiple settings.
Short Description: In this analysis of a pivotal study of the d-amphetamine transdermal system (d-ATS) for ADHD in children and adolescents, a significant difference between placebo and the optimized dose of d-ATS in each of the parent-rated CPRS-R:S subscale scores (oppositional, cognitive problems/inattention, hyperactivity, and ADHD index) was observed. These results indicate that d-ATS was effective in treating ADHD across a spectrum of disruptive behaviors in children and adolescents.
Name of Sponsoring Organization(s): Noven Pharmaceuticals, Inc.
