The US FDA has approved Shire Pharmaceuticals' Adderall XR (mixed salts of a single-entity amphetamine product) as a once-daily treatment for adolescents aged 13 to 17 with attention deficit hyperactivity disorder (ADHD). Since October 2001, Adderall XR has been approved in the US for treatment in children aged 6 to 12 years and since August 2004 in adults 18 years and older. Adderall XR is currently the most commonly prescribed brand of ADHD medication in the United States, a company release said here.

"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," Dr. Timothy Wilens of Massachusetts General Hospital explained adding, "The symptoms of ADHD often continue past childhood into adolescence and adulthood, where they can have a significant impact on an individual's family, academic performance, and overall quality of life. Stimulant therapies are effective and generally well tolerated, and have been used medically in patients for more than 60 years."

ADHD affects approximately 3 to 7 per cent 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 new adolescent labelling for Adderall XR offers health care providers, parents and patients continuity in the management of ADHD symptoms as children become older," said Greg Flexter, executive vice president and general manager, Shire North America.

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.