(#3) Effect of Centanafadine on the AIM-A After 6 Weeks of Treatment in Adults with ADHD: A Pooled Analysis of Two Phase 3 Trials

Abstract: Objective: ADHD is a chronic and prevalent neurodevelopmental disorder in adults, characterized by symptoms of inattention, hyperactivity, and impulsivity. This pooled analysis of 2 phase 3 trials evaluated the effect of centanafadine (CTN)óa norepinephrine, dopamine, serotonin reuptake inhibitoróon the quality of life (QoL) of adults with ADHD. Methods: Data from 2 identically designed phase 3 trials were pooled. Eligible patients aged 18-55 years with a primary ADHD diagnosis per DSM-5 were randomized to receive CTN 200 or 400mg/day or placebo. Exploratory endpoints included change from baseline in ADHD Impact Module-Adult (AIM-A), a self-reported QoL assessment, at Week 6. Endpoints were analyzed using a mixed-effects model for repeated measure without adjusting for multiplicity and are therefore descriptive. Results: Overall, 859 adults (mean age 35y, 52% male) were randomized to CTN 200mg (n=287), CTN 400mg (n=287), or placebo (n=285). CTN demonstrated clinically meaningful improvement on the AIM-A multi-item summary scores vs placebo. For CTN 200 and 400mg, the treatment difference vs placebo in summary scores of Living With ADHD was 4.43 and 3.79 (both P 0.001), respectively; General Well-Being was 5.27 (P 0.0001) and 3.56 (P 0.005); Performance and Daily Functioning was 8.45 (P 0.0001) and 6.62 (P 0.0002); Impact of Symptoms: Bother/Concern was 8.19 (P 0.0001) and 5.44 (P 0.0009). Similar clinically meaningful improvement was observed on the global QoL items for CTN vs placebo, including Current QoL, Global Limitations, and More Good Days Than Bad Days. Conclusions: Treatment with CTN is associated with clinically meaningful improvement on core health-related QoL domains in adults with ADHD.Short Description: Centanafadine (CTN)óa norepinephrine, dopamine, serotonin reuptake inhibitoróimproved the overall functioning and well-being of adults with ADHD. After 6 weeks, treatment led to symptom improvements that aligned with clinically meaningful change on core health-related quality of life domains, as measured by the ADHD Impact Module for Adults (AIM-A)óa validated tool assessing the impact of ADHD on daily functioning, emotional well-being, and social relationships.Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc.