Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in the Treatment of Children With Attention-Deficit/Hyperactivity Disorder

Objective: Determine if AMPH EROS has an onset of effect at 30 minutes post-dose in children with ADHD.

Methods: Randomized, double-blind, 2-treatment, 2-sequence, placebo-controlled crossover pilot study enrolled subjects 6-12 years with ADHD. A dose of 5-20 mg/day of AMPH EROS was optimized during a 1-week open-label phase based on medication history, symptom control, and tolerability. Subjects completed a practice laboratory classroom then received one day of double-blind AMPH EROS or placebo each in sequence during 2 double-blind laboratory classroom days. Subjects completed the first double-blind laboratory classroom, returned to open label drug for 5 days then crossed over on day 6 during a second double-blind laboratory classroom. Double blind dose was AMPH EROS 15, 17.5, or 20 mg. Primary endpoint was change from predose in SKAMP-C score measured at 30 minutes on two double blind days. Key secondary endpoint was change from predose in SKAMP-C after 3 hours for AMPH EROS vs placebo. Safety included vital signs and adverse events.

Results: Eighteen subjects enrolled (14 males); mean age of 9 years. At 30 minutes and 3 hours postdose, changes from baseline in SKAMP-C for AMPH EROS vs. placebo were statistically significant (p<0.01 and p=0.0002, respectively) with corresponding effect sizes of 0.96 and 1.57. Adverse events (>10%) during the open-label phase included upper respiratory tract infection, fatigue, upper abdominal pain, headache, decreased appetite, and affect lability.

Conclusions: AMPH EROS was effective in reducing ADHD symptoms at 30 minutes postdose. AEs were mild and consistent with those of other ER amphetamines.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.