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Once-daily atomoxetine reduced ADHD symptoms into the evening

INDIANAPOLIS, IND, Nov. 1, 2002 -- A once-daily dose of atomoxetine, an investigational compound being developed by Eli Lilly, significantly reduced core symptoms of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents, according to a paper published in the November issue of the American Journal of Psychiatry (Volume 159, Number 11).

Symptom reduction lasted into the evening without causing insomnia. Other studies have shown no significant differences in insomnia between atomoxetine and placebo. Atomoxetine is a selective norepinephrine reuptake inhibitor.

The 6-week, randomized, placebo-controlled study of 171 patients found atomoxetine significantly reduced overall ADHD symptoms as well as inattentive and hyperactive/impulsive symptoms, as assessed by parents, teachers and clinical investigators. This was the first atomoxetine study to provide evidence of effect based on teacher ratings.

In addition, parent ratings, using a diary scale developed by Eli Lilly, suggested atomoxetine continued to work late in the day, significantly reducing inattention during late afternoon/early evening, and reducing difficulties settling at bedtime.

"Effective treatment of ADHD involves not only a reduction of ADHD symptoms, but also an improvement in social and family function," said study co-author Jeffrey Newcorn, M.D., Associate Professor of Psychiatry and Pediatrics, Mount Sinai School of Medicine, and Director, Division of Child and Adolescent Psychiatry, Mount Sinai Medical Center. "A treatment that provides symptom control into the evening has the potential to significantly improve family interactions."

"The most striking finding of this study is the suggestion that one dose of atomoxetine in the morning produced symptom improvements that persisted into the evening, despite the short plasma half-life of the medication, and without causing insomnia," said lead author David Michelson, M.D., Medical Director, Eli Lilly and Company.

Atomoxetine showed greater improvement than placebo on two items tracked in the parent diaries: inattention during late afternoon and early evening, and difficulty settling at bedtime. The average scores for "inattentive and distractable during the evening" fell 36.8 percent for patients on atomoxetine, from 1.9 to 1.2. That compares with a reduction from 1.8 to 1.5, or 16.7 percent, for patients on placebo. The average scores for difficulty settling at bedtime fell from 1.8 to 1.1, or 38.9 percent, for patients on atomoxetine, compared with a reduction from 1.7 to 1.4, or 17.6 percent, for those on placebo. Other aspects of behavior were tracked in the parental diaries, but changes observed were not statistically significant.

Interpretation of the results is limited by several factors. This study did not include a twice-daily dosing arm, therefore no direct comparison of the relative efficacy of once- versus twice-daily atomoxetine administration can be definitively determined. Also, the dose range used in this study was based on the results of a dose-response study that employed twice-daily dosing, and it is possible that a different range would be optimal for once-daily dosing.

Lilly received an approvable letter from the FDA for Strattera (atomoxetine hydrochloride) in August 2002. If approved by regulators, atomoxetine will be the first new class of medication for ADHD in decades. It also will be the only medication indicated for the treatment of ADHD that is not a stimulant.

Source: Eli Lilly and Company

Posted: November 2002