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Strattera FDA-Approved for ADHD Maintenance


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By: Tim Wright

Editor-in-Chief, Contract Pharma

Eli Lilly and Co. received approval from the FDA for Strattera 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 an 18-month trial of about 600 pateints aged six to 15 years, who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD. The study showed Strattera was superior to placebo in maintaining continuous efficacy in patients, as measured by the ADHD Rating Scale (ADHD-RS). Additionally, patients taking Strattera had lower relapse rates (3%) as compared to patients taking placebo (12%). Strattera was generally well tolerated. The most common side effects reported in the study were headache and the common cold (nasopharyngitis).  

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