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Evekeo safe, effective for ADHD among children in classroom setting

Amphetamine sulfate was effective and well-tolerated among children with attention-deficit/hyperactivity disorder, with an effect onset of 45 minutes that continued through 10 hours post-dosing, according to results from a dose-optimized, double-blind, randomized, placebo-controlled, crossover laboratory classroom study.

“The primary objective of the current study was to establish that an optimal dose of [Evekeo (amphetamine sulfate, Arbor Pharmaceuticals Inc.)] in children 6 to 12 years old diagnosed with ADHD would result in a significant reduction in ADHD signs and symptoms compared to placebo at 2 hours postdose in a laboratory classroom, while characterizing the onset of effect and duration of action for the medication,” study researcher Ann C. Childress, MD, of the Center for Psychiatry and Behavioral Medicine in Las Vegas, and colleagues wrote.

Ann C. Childress

During the 8-week open-label dose-optimization phase, 107 children aged 6 to 12 years with ADHD were instructed to take 5 mg of amphetamine sulfate twice daily. This dose was titrated weekly in 5 mg increments until an optimal dose based on clinical response and tolerability was achieved. After 8 weeks of treatment, study participants who tolerated 10 mg of amphetamine sulfate were randomly assigned to receive amphetamine sulfate followed by placebo (n = 47) or placebo followed by amphetamine sulfate (n = 50) for 2 weeks. Efficacy was assessed via the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP) prior to dosing and 0.75, 2, 4, 6, 8 and 10 hours after dosing on 2 days in the laboratory classroom.

Amphetamine sulfate significantly improved SKAMP-combined scores compared with placebo at each time point tested during laboratory classroom days (P < .0001). The treatment had an effect onset of 45 minutes with a duration of 10 hours.

When study participants received amphetamine sulfate, they attempted more problems on the PERMP and answered more correctly than when they received placebo at each tested time point in the laboratory classroom (P < .0001).

During the open-label dose-optimization phase, children who received amphetamine sulfate had improved scores on the ADHD-Rating Scale IV and Clinical Global Impressions Severity and Improvement Scales.

The most common treatment-associated adverse events were decreased appetite (27.6%), upper abdominal pain (14.3%), irritability (14.3%) and headache (13.3%).

“Results from this trial indicate that [amphetamine sulfate] is effective in the treatment of ADHD in subjects 6 to 12 years of age when dosed once or twice daily. [Amphetamine sulfate] received FDA approval for treatment of ADHD in children at least 3 years of age or older in September 2014,” the researchers concluded. – by Amanda Oldt

Disclosure: Childress reports serving as a consultant and/or speaker and receiving research support from Bristol-Myers Squibb, Ironshore Pharmaceuticals, Neos Therapeutics, NextWave Pharmaceuticals, Novartis, Pfizer, Rhodes Pharmaceuticals, Shionogi Pharma and Shire Pharmaceuticals, and receiving research support from Arbor Pharmaceuticals, Eli Lilly, Forest Research Institute, Johnson and Johnson, Neurovance, Noven Pharmaceuticals, Ostuka Pharmaceutical, Purdue Pharma, Sunovion Pharmaceuticals, Therovance Biopharma and Tris Pharma. Please see the full study for a list of all other authors’ relevant financial disclosures.