United States Food and Drug Administration (FDA) has approved Eli Lilly Strattera (atomoxetine HCI) for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults.
The safety and efficacy of Strattera in the maintenance of ADHD was demonstrated in one of the largest relapse prevention studies ever conducted in ADHD, which is one of the most common mental health disorders in children and adolescents.
The 18-month trial of about 600 children and adolescents aged six to 15 years, who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD, showed Strattera was superior to placebo in maintaining continuous efficacy in patients, as measured by the ADHD Rating Scale (ADHD-RS). Additionally, at the end of the trial, patients taking Strattera had lower relapse rates (2.5 %) as compared to patients taking placebo (12.2%).
Strattera provides uninterrupted relief from ADHD symptoms throughout the day into the evening. This is important since the symptoms of ADHD go beyond the work and school day. ADHD patients can experience frustration, low self-esteem, difficulty with relationships and increased lifestyle risks.
The long-term, international, multi-centre study, which was reviewed by the FDA as part of its decision to grant this approval, employed a treatment discontinuation design that enabled investigators to test the efficacy of Strattera as maintenance therapy. In the study, 604 patients initially received acute open label treatment with Strattera.
After 10-weeks, 69% of patients qualified as responders and were re-randomized to double-blind treatment with either Strattera or placebo for nine months. A second six-month randomization occurred after approximately one year of treatment with 81 patients taking Strattera and 82 patients in the placebo group.
Results of both randomization phases showed that patients treated with Strattera had significantly greater continuous response rates versus patients taking placebo. Strattera was generally well tolerated. The most common side effects reported in the study were headache and the common cold (nasopharyngitis). In the study, the mean final dose of Strattera was approximately 1.54 mg/kg/day after 12 months and 18 months treatment. There were no significant differences in standardized height change between groups during the post-randomization period.