Abstract
Objectives: To determine the efficacy and safety of amphetamine extended-release oral suspension (AMPH EROS) in the treatment of attention-deficit/hyperactivity disorder (ADHD) in a dose-optimized, randomized, double-blind, parallel-group study.Methods: Boys and girls aged 6 to 12 years diagnosed with ADHD were enrolled. During a 5-week, open-label, dose-optimization phase, patients began treatment with 2.5 or 5 mg/day of AMPH EROS; doses were titrated until an optimal dose (maximum 20 mg/day) was reached. During the double-blind phase, patients were randomized to receive treatment with either their optimized dose (10–20 mg/day) of AMPH EROS or placebo for 1 week. Efficacy was assessed in a laboratory classroom setting on the final day of double-blind treatment using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP) test. Safety was assessed measuring adverse events (AEs) and vital signs.Results: The study was completed by 99 patients. The primary efficacy endpoint (change from predose SKAMP-Combined score at 4 hours postdose) and secondary endpoints (change from predose SKAMP-Combined scores at 1, 2, 6, 8, 10, 12, and 13 hours postdose) were statistically significantly improved with AMPH EROS treatment versus placebo at all time points. Onset of treatment effect was present by 1 hour postdosing, the first time point measured, and duration of efficacy lasted 13 hours postdosing. PERMP data mirrored the SKAMP-Combined score data. AEs (>5%) reported during dose optimization were decreased appetite, insomnia, affect lability, upper abdominal pain, mood swings, and headache.Conclusion: AMPH EROS was effective in reducing symptoms of ADHD and had a rapid onset and extended duration of effect. Reported AEs were consistent with those of other extended-release amphetamine products.
Highlights
Attention-deficit/hyperactivity disorder (ADHD) is prevalent in the United States, with a reported 11% of schoolaged children affected (Visser et al 2014)
Onset of efficacy occurred at the earliest postdose time point at which a statistically significant ( p < 0.05) treatment difference was found, and duration of efficacy was the difference between onset time and the last consecutive time point at which the treatment difference was still statistically significant ( p < 0.05)
A significant separation from placebo occurred at each postdose time point assessed (1, 2, 4, 6, 8, 10, 12, and 13 hours), with onset of action of AMPH EROS at 1 hour postdose and duration of efficacy extending to 13 hours postdose ( p < 0.0001)
Summary
Attention-deficit/hyperactivity disorder (ADHD) is prevalent in the United States, with a reported 11% of schoolaged children (i.e., more than 6.4 million based on 2011 estimates) affected (Visser et al 2014). Clinical practice guidelines recommend pharmacologic treatment with psychostimulants (with or without behavioral intervention), including amphetamine, as firstline medical treatment for ADHD in patients who have no comorbid disorders Issues 2007; Subcommittee on Attention-Deficit/Hyperactivity Disorder et al 2011). Preschool-aged children with ADHD should receive behavioral therapy alone before medication is considered (subcommittee on Attention-Deficit/Hyperactivity Disorder et al 2011). Extended-release (ER) formulations that obviate the need for multiple doses per day and/or dosing during school hours are generally preferred over immediate-release formulations (Pliszka and AACAP Work Group on Quality Issues 2007).
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