Efficacy and Safety of PRC-063 for Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-analysis From Randomized Controlled Trials

Abstract

Objective: A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. This meta-analysis was conducted to study the efficacy and safety of PRC-063 for ADHD. Method: We searched for published trials to October 2022 in several databases. Results: A total of 1,215 patients from 5 RCTs were included. We observed significant improvement for PRC-063 in ADHD Rating Scale (ADHD-RS; MD = −6.73, 95% CI [−10.34, −3.12]) compared with placebo. The effect of PRC-063 on the sleep problems due to ADHD was not statistically different from placebo. Six subscales of Pittsburg Sleep Quality Index (PSQI) showed no statistical significance between PRC-063 and placebo. The result showed no significant difference comparing PRC-063 with placebo in serious treatment-emergent adverse events (TEAEs) (RR = 0.80, 95% CI [0.03, 19.34]). In subgroup analysis according to age, PRC-063 was more efficacious in minors compare to adults. Conclusion: PRC-063 is an efficacious and safe treatment for ADHD, especially in children and adolescents.