Aderall XR is already approved for the treatment of attention deficit hyperactivity disorder (ADHA) in children aged 6 to 12, and also in adults aged 18 years and over. This FDA approval will now expand the indication of what is already the most commonly prescribed brand of ADHD medication in the US.
“There has long been an unmet need for ADHD research and treatment among the adolescent population despite an increasing awareness of ADHD’s potential impact on quality of life. Therefore, approval of an ADHD treatment for this under identified age group is an important milestone,” explained Dr Timothy Wilens of Massachusetts General Hospital.
ADHD affects approximately 3-7% of all school-age children, or approximately two million US children, and is considered the most commonly diagnosed psychiatric disorder in children and adolescents. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable age and maturity.
The FDA based its approval on data that Shire provided in a supplement to its New Drug Application (sNDA). These data included the results of a pharmacokinetic study and a placebo-controlled, fixed-dose clinical trial of a range of doses of once-daily Adderall XR in adolescents with ADHD.