FDA clears Lilly's Strattera in ADHD maintenance

The US Food and Drug Administration has approved domestic drug major Eli Lilly's Strattera (atomoxetine HCI) for maintenance treatment of attention-deficit hyperactivity disorder in children and adolescents. The drug, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults, the company notes.

"The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD," said Thomas Spencer, associate professor of psychiatry, Harvard Medical School. "This is critical as ADHD may be a life-long disease and effective long-term control of symptoms may mean improved outcomes in children and adolescents," he added.

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 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%).