A new study has found Dyanavel® XR (Amphetamine Extended-Release Oral Suspension; AMPH EROS) to be effective in reducing symptoms of attention-deficit/hyperactivity disorder (ADHD) with a rapid onset and extended duration of effect.
The goal of this study, whose results were presented at AMCP Nexus 2019, was to determine the efficacy and safety of AMPH EROS in treating ADHD compared to a placebo. This dose-optimized, randomized, double-blind study evaluated AMPH EROS in a laboratory classroom setting involving 108 pediatric patients (aged 6 to 12 years) with ADHD. The study began with a five-week open-label dose optimization, using an initial AMPH EROS dose of 2.5 mg or 5 mg once daily in the morning.
The dose could be titrated in increments of 2.5 mg to 10 mg every 4 to 7 days until an optimal dose was achieved, or if the maximum dose of 20 mg/day was reached. The pediatric participants then went through a one-week randomized, double-blind treatment phase with either their personally optimized dose or placebo. At the end of the treatment week, the participants were evaluated by raters for their attention and behavior in a laboratory classroom. This rating was done in accordance with the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP-C) rating scale. SKAMP-C is a 13-item teacher-rated scale designed to assess ADHD symptom expression in the classroom setting.
The primary endpoint of this study was the change from pre-treatment in SKAMP-C scores four hours after the drug was administered. The key secondary endpoint parameters were onset and duration of clinical effect. Changes in SKAMP-C scores from pre-treatment to post-treatment time points of one, two, six, eight, 10, 12 and 13 hours were used to assess these key secondary efficacy endpoints.
The participant pool was comprised of more males (68.7%) than females, with 55.6% of the participants being white. Most of the patients included had inattentive or combined type ADHD presentations. The primary endpoint, the change from pre-treatment SKAMP-C score at 4 hours post-treatment, was found to improve significantly (P<0.0001) in comparison to the placebo. Furthermore, the researchers also found that the secondary efficacy endpoints were also significantly improved (P<0.0001 at each time point) compared to the placebo group. Reported adverse events (frequency >5%) during the dose optimization phase included decreased appetite, insomnia, affect lability, pain in the upper abdomen, headache, and mood swings.
“AMPH EROS was effective in reducing symptoms of ADHD from one to 13 hours after dosing,” the researchers concluded. “Adverse events reported were consistent with those of other amphetamine products.”
Poster Presentation: Childress, A, Pardo, A, et al. Efficacy and Safety of Dyanavel®XR (Amphetamine Extended-Release Oral Suspension; AMPH EROS) in Children with ADHD. Presented at: AMCP Nexus 2019; October 29 – Nov 1; National Harbor, MD.