Strattera is a selective norepinephine reuptake inhibitor, a new class of treatment that works differently from the other attention-deficit/hyperactivity disorder medications available.

Strattera is not a stimulant under the Controlled Substance Act.

Strattera is an oral capsule and can be taken once or twice a day. Capsules are supplied in 5, 10, 18, 25, 40, and 60-mg strengths.

The safety and effectiveness of Strattera in the treatment of ADHD was established in six randomized, double-blind, placebo-controlled studies in children, adolescents, and adults who met Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD.

Children and adolescents:

In Study 1, an 8-week randomized, double blind, placebo-controlled, dose-response, acute treatment study of children and adolescents aged 8 to 18 (N=297), subjects received either a fixed dose of (0.5, 1.2, or 1.8 mg/kg/day) or placebo. Strattera was administered as a divided dose in the early morning and late afternoon/early evening. At the 2 higher doses, improvements in ADHD symptoms were statistically significantly superior in Strattera treated subjects compared with placebo-treated subjects as measured on the ADHDRS scale. The 1.8-mg/kg/day Strattera dose did not provide any additional benefit over that observed with the 1.2-mg/kg/day dose. The 0.5-mg/kg/day Strattera dose was not superior to placebo.

In Study 2, a 6-week randomized, double blind, placebo-controlled, acute treatment study of children and adolescents aged 6 to 16 (N=171), subjects received either Strattera or placebo. Strattera was administered as a single dose in the early morning and titrated on a weight-adjusted basis according to clinical response, up to a maximum dose of 1.5 mg/kg/day. The mean final dose of Strattera was approximately 1.3 mg/kg/day. ADHD symptoms were statistically significantly improved on Strattera compared with placebo, as measured on the ADHDRS scale. This study shows that Strattera is effective when administered once daily in the morning.

In 2 identical, 9-week, acute, randomized, double blind, placebo-controlled studies of children aged 7 to 13 (Study 3, N=147; Study 4, N=144), Strattera and methylphenidate were compared with placebo. Strattera was administered as a divided dose in the early morning and late afternoon (after school) and titrated on a weight-adjusted basis according to clinical response. The maximum recommended Strattera dose was 2.0 mg/kg/day. The mean final dose of Strattera for both studies was approximately 1.6 mg/kg/day. In both studies, ADHD symptoms statistically significantly improved more on Strattera than on placebo, as measured on the ADHDRS scale. Examination of population subsets based on gender and age (<12 and 12 to 17) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

Adults:

The effectiveness of Strattera in the treatment of ADHD in adults was established in 2 randomized, double blind, placebo-controlled clinical studies of adult patients, age 18 and older, who met DSM-IV criteria for ADHD. Signs and symptoms of ADHD were evaluated using the investigator-administered Conners Adult ADHD Rating Scale Screening Version (CAARS), a 30-item scale. The primary effectiveness measure was the 18-item Total ADHD Symptom score (the sum of the inattentive and hyperactivity/impulsivity subscales from the CAARS) evaluated by a comparison of mean change from baseline to endpoint using an intent-to-treat analysis.

In 2 identical, 10-week, randomized, double blind, placebo-controlled acute treatment studies (Study 5, N=280; Study 6, N=256), patients received either Strattera or placebo. Strattera was administered as a divided dose in the early morning and late afternoon/early evening and titrated according to clinical response in a range of 60 to 120 mg/day. The mean final dose of Strattera for both studies was approximately 95 mg/day. In both studies, ADHD symptoms were statistically significantly improved on Strattera, as measured on the ADHD Symptom score from the CAARS scale. Examination of population subsets based on gender and age (<42 and > 42) did not reveal any differential responsiveness on the basis of these subgroupings. There was not sufficient exposure of ethnic groups other than Caucasian to allow exploration of differences in these subgroups.

Adverse events associated with the use of Strattera (atomoxetine HCl) may include (but are not limited to) the following:

• Abdominal pain
• Constipation
• Dyspepsia
• Vomiting
• Ear infection
• Influenza
• Weight decreased
• Irritability
• Mood swings
• Dry mouth
• Nausea
• Appetite decreased
• Insomnia

STRATTERA (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-Nmethyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride.

The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

For additional information on Strattera (atomoxetine HCl), please contact The Eli Lilly and Company Web Site