The US Food and Drug Administration has approved Shire Pharmaceuticals’ key ADHD offering, Adderall XR (mixed amphetamine salts extended-release) as a once-daily treatment for adolescents aged 13 to 17 with the condition.
Approval was based on data showing that Adderall XR was significantly more effective than placebo in the treatment of ADHD symptoms in adolescents, with, 63% of investigators considering their subjects’ ADHD symptoms to be much improved or very much improved with Adderall XR, versus 27% for placebo.
The once daily formulation was approved in October 2001 to treat children aged six to 12 [[15/10/01a]], and won the green light in August last year for adults over the age of 18 [[12/08/04b]]. Adderall is one of Shire’s top selling drug, bringing in 2004 sales of some $607 million dollars – up 28% [[03/03/05d]]. However, it is currently facing generic threats from a number of companies and Shire has already filed lawsuit against Barr and Impax, with the cases set to go to court in January and February 2006 respectively [[20/07/05g]].
“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 underidentified age group is an important milestone,” explained Dr Timothy Wilens of Massachusetts General Hospital. “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.”
ADHD affects around 3% to 7% of all school-age children – about 2 million children in the US alone – and, as they age, up to 65% of adolescents with ADHD may still exhibit symptoms into adulthood.