New study supports safety and efficacy of Evekeo for treating children with ADHD
The amphetamine-based drug Evekeo, given once or twice daily to children 6-12 years of age, is effective in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and improving performance in a laboratory classroom setting, according to the results of a new study published in the Journal of Child and Adolescent Psychopharmacology, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available Open Access on the Journal of Child and Adolescent Psychopharmacology website.
Ann C. Childress, MD, Center for Psychiatry and Behavioral Medicine, Las Vegas, NV, and coauthors compared the safety and efficacy of Evekeo (a racemic formulation with a ratio of 1:1 D- and L-amphetamine [R-AMPH]) versus placebo using rating scales and performance measures designed to assess ADHD symptoms as well as behavior and productivity in the classroom.
In "The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study," the authors describe the safety profile of Evekeo and treatment-emergent adverse events (TEAEs). They report significant improvement in ADHD rating scores with a single daily dose of R-AMPH, on the laboratory classroom days, beginning at 45 minutes postdose and extending through 10 hours. Scores for ADHD signs and symptoms improved among the children receiving twice daily R-AMPH during the initial dose-optimization phase of the study. TEAEs and changes in vital signs associated with R-AMPH were generally mild and not unexpected.
Evekeo (Arbor Pharmaceuticals, Atlanta, GA) received FDA approval for treatment of ADHD in patients 3 years of age or older in September 2014.
Source:Journal of Child and Adolescent Psychopharmacology