SOURCE: Eli Lilly & Company

May 26, 2005 10:27 ET

New Data Suggest Once-Daily Atomoxetine May Provide Symptom Relief for up to 24 Hours

Data Showed That Morning and Evening Dosing Produced Similar Results

ATLANTA, GA -- (MARKET WIRE) -- May 26, 2005 -- Once-daily treatment with atomoxetine HCl, approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), produced core symptom reductions in children and, in a secondary analysis, were sustained up to 24 hours according to a study presented today at the 158th annual meeting of the American Psychiatric Association.

Atomoxetine was dosed in either the morning or the evening. This study found morning or evening dosing produced similar core symptom reduction based on the ADHD-RS, a scale which assesses 18 individual symptoms related to ADHD (nine assess inattentive symptoms and the other nine assess hyperactive and impulsive symptoms). This is the second placebo-controlled study that found atomoxetine was effective in providing continuous symptom relief in children.

"Atomoxetine's ability to control symptoms of ADHD demonstrated in this study for up to 24 hours provides physicians with a flexible option for treating ADHD in children," said Humberto Quintana, Associate Professor of Psychiatry, Louisiana State University School of Medicine at New Orleans, and a lead investigator on the study.

Additional Study Results

-  Both morning and evening dosing produced significantly greater
   decreases than placebo at endpoint on the following scales:
   -  ADHD-RS total score: 17.76 (41 percent) improvement with morning
      dosing, 13.45 (32 percent) improvement with evening dosing, vs.
      9.51 (22 percent) with placebo. Overall comparison with placebo
      p < .001 for morning dosing, p=.009 for evening dosing.
   -  Daily Parent Rating of Evening and Morning Behavior-Revised Scale
      Total (DPREMB-R), a secondary analysis:  3.61 (26 percent)
      improvement with morning dosing, 4.85 (32 percent) improvement
      with evening dosing vs. 2.66 (17 percent) improvement with
      placebo.
      Overall comparison with placebo p=.028 for morning dosing, p=.023
      for evening dosing.
   -  Conners' Global Index: Parent-Morning scale (CGIP-M) Total, a
      secondary analysis: 5.62 (34 percent) improvement with morning
      dosing, 6.02 (39 percent) improvement with evening dosing vs.
      4.10 (26 percent) improvement with placebo. Overall comparison
      with placebo p=.023 for morning dosing, p=.024 for evening
      dosing.
   -  Conners' Global Index: Parent-Evening scale (CGIP-E) Total: 5.82
      (31 percent) improvement with  morning dosing, 4.46 (23 percent)
      improvement with evening dosing vs. 2.03 (11 percent) improvement
      with placebo. Overall comparison with placebo p < .001 for
      morning dosing, p=.002 for evening dosing.
-  The most common treatment adverse events reported for patients on
   atomoxetine included upper abdominal pain, decreased appetite,
   vomiting, headache, somnolence, nausea and stomach discomfort.
"Atomoxetine offers the convenience of morning or evening dosing, allowing parents to work with physicians to decide what dosing regimen best fits into their child's daily routine," said Douglas Kelsey, MD, Senior Research Physician, Eli Lilly and Company.

Methods

--  288 children (aged 6-12) were randomized to receive atomoxetine in the
    morning and placebo in the evening (n=102), placebo in the morning and
    atomoxetine in the evening (n=93) or placebo in the morning and evening
    (n=93) for approximately six weeks. (Approved dosing is once or twice
    daily).
--  Patients receiving atomoxetine (n=195) had a starting dose of
    .8mg/kg/day for three days and increased to the target dose of 1.2
    mg/kg/day thereafter.  Maximum dose was 1.4 mg/kg/day but did not exceed
    100mg regardless of patient's weight. (Approved starting label dose is
    0.5mg/kg/day for children and adolescents up to 70kg).
--  Parent assessments of children's home behaviors in the evening and
    early morning were collected using the DPREMB-R and CGIP-M and CGIP-E
    scales.
    
About ADHD

ADHD affects three-seven percent of school-age children and manifests itself in levels of attention, concentration, activity, distractibility and impulsivity that are inappropriate to the child's age.(1) In addition, 60 percent of children with the disorder carry their symptoms into adulthood.(2) Experts estimate four percent of adults in the United States, more than eight million people, have ADHD.(3,4)

About Atomoxetine

Atomoxetine, a selective norepinephrine reuptake inhibitor, is approved to treat ADHD in children aged six and over, adolescents, and adults. It is not known precisely how atomoxetine reduces ADHD symptoms, but scientists believe it works by blocking or slowing reabsorption of norepinephrine, a chemical in the brain considered important in regulating attention, impulsivity and activity levels. This keeps more norepinephrine at work in the spaces between neurons in the brain. Improved efficiency in the norepinephrine system is associated with improvement in symptoms of ADHD (Pliska, 1996).

Atomoxetine should not be taken at the same time as, or within two weeks of taking, a monoamine oxidase inhibitor (MAOI) or by patients with narrow angle glaucoma. Patients with a history of high or low blood pressure, increased heart rate, or any heart or blood vessel disease should tell their doctor before taking atomoxetine. Atomoxetine has not been tested in children less than six years of age or in geriatric patients. Some children may lose weight when starting treatment with atomoxetine. As with all ADHD medications, growth should be monitored during treatment. Atomoxetine can cause liver damage in rare cases. Patients should tell their doctor right away if they have itching, dark urine, yellow skin/eyes, upper right-sided abdominal tenderness, or unexplained "flu-like" symptoms.

Most people in clinical studies who experienced side effects were not bothered enough to stop using atomoxetine. The most common side effects in children and adolescents in medical studies were upset stomach, decreased appetite, nausea and vomiting, dizziness, tiredness and mood swings. In adults, the most common side effects were constipation, dry mouth, nausea, decreased appetite, dizziness, problems sleeping, sexual side effects, problems urinating and menstrual cramps.

About Lilly

Lilly (NYSE: LLY), a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

1. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, Washington, DC, American Psychiatric Association, 2000.

2. Schweitzer JB, et al. Attention-deficit/hyperactivity disorder. Med Clin of North Am. 2001; 85(3): 757-777

3. Murphy K, Barkley, RA. J Atten disord. 1996; 1:147-161.

4. United States Census Summary File; 2000.

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