The FDA approval was based on clinical trial data in adults ages 18 to 65. In these studies, use of Concerta was shown to significantly improve ADHD symptoms such as attention, impulsivity and hyperactivity compared to placebo, and the medication was shown to be generally well tolerated.
The approval expands the Concerta indication from children and adolescents into adults with ADHD, and offers these patients a patented once- daily formulation.
Using its unique OROS delivery system, the Concerta formulation delivers an initial dose of medication when the tablet is ingested. Medication is then delivered into the bloodstream at a controlled rate throughout the day.