FDA extends indication for ADHD treatment formulation to adolescent years

October 5, 2005

The US Food and Drug Administration (FDA) recently approved Adderall XR (an extended-release formulation of mixed salts of amphetamine) as a once-daily treatment for attention deficit hyperactivity disorder in adolescents 13 to 17 years old. That action bridges an "indication gap" between earlier approval of the product for patients 6 to 12 years old and for older (18 years) adolescents and adults.

The US Food and Drug Administration (FDA) recently approved Adderall XR (an extended-release formulation of mixed salts of amphetamine) as a once-daily treatment for attention deficit hyperactivity disorder in adolescents 13 to 17 years old. That action bridges an "indication gap" between earlier approval of the product for patients 6 to 12 years old and for older (18 years) adolescents and adults.

The FDA based its approval on data that the drug's manufacturer, Shire Pharmaceuticals, provided in a supplement to its new drug application, including 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. In a randomized, double-blind, placebo-controlled clinical trial, the drug was more effective than placebo in treating the symptoms of ADHD symptoms in this group of patients.