Introduction
Attention-deficit/hyperactivity disorder, ADHD, SE, neurodevelopmental disorder, gastrointestinal (GI) tract
Attention-deficit/hyperactivity disorder (ADHD) is recognized as a widespread neurodevelopmental disorder with major public health implications worldwide (Faraone et al, These studies typically evaluate efficacy by comparing the active drug treatment with placebo using a range of ADHD rating scales (ADHD-RSs) including the ADHD-RS; the Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) complete and subscale scores (Wigal and Wigal, As the number of available agents for treatment of ADHD increases, the need for evaluation of one agent relative to another becomes of increasing importance. Direct comparisons of efficacy data from studies, whether by direct comparisons of mean difference in change relative to placebo, or by comparing Therefore, an effect size estimate places an interpretable value on the direction and magnitude of an effect of a treatment. This measure of effect can then be used to compare the efficacy of the treatment in question with similarly computed measures of treatment efficacy in other studies that may use seemingly noncomparable measures (Faraone and Buitelaar, Amphetamine extended-release oral suspension (AMPH EROS; Tris Pharma, Inc., Monmouth Junction, NJ, USA) is an amphetamine base product, 3.2:1 mixture of The technology consists of ionically binding drug particles to a micron-sized resin, which is then covered with a permeable coating. Mechanistically, after ingestion drug particles leave the resin and enter the gastrointestinal (GI) tract. To accomplish this, positively charged ions from the GI fluids diffuse across the coating where they displace the ionically charged drug product, which diffuses back through the coating and into the GI fluids for absorption. As the coating is of variable thickness, some drug product takes longer to diffuse and absorb, providing for the programmable delayed drug release characteristic (Herman et al, The efficacy and safety of AMPH EROS as a treatment for ADHD were previously established in a laboratory classroom study (Childress et al, The primary efficacy endpoint was change from predose SKAMP-C score at 4 hours postdose. Secondary endpoints were the change from predose SKAMP-C scores at intervals from 1 to 13 hours postdose. Onset and duration of efficacy were defined as the first and last measured time point that reached statistical significance. The study was completed by 99 subjects. The primary efficacy endpoint was met (least-squares [LS] mean treatment difference [95% confidence interval; CI] of −14.8 [−17.9 to −11.6], The duration of efficacy persisted until the final time point at 13 hours postdose (treatment difference LS mean [SE], −9.2 [1.61], 