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Strattera (Atomoxetine) Now Approved In Canada

Posted by jrbecker on January 6, 2005, at 19:09:17,67418810,274,f/

Strattera (Atomoxetine), Non-Stimulant Medication For Attention-Deficit/Hyperactivity Disorder, Now Approved In Canada
TORONTO, ON -- January 6, 2005 -- Strattera™ (atomoxetine) is the first and only non-stimulant medication ever approved in Canada for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Strattera (pronounced "Stra-tair-a") is a selective norepinephrine reuptake inhibitor, and the first in a new class of ADHD medications since stimulants became available 50 years ago. It is approved for the treatment of ADHD in children six years of age and over, adolescents, and adults.

"This marks the beginning of a new era in ADHD treatment because for the first time, physicians and patients have a non-stimulant option that can offer relief of symptoms throughout the entire day," said Dr. Atilla Turgay, Chief of Medical Staff, Director ADHD Clinic, Training and Research Institute, The Scarborough Hospital, Toronto, Ontario. "As a clinical trial investigator, I know that relief of ADHD symptoms can help improve patients and families' quality of life, contributing to overall family functioning, and can have a beneficial effect on the child's behaviour at school and self esteem."

In clinical trials, Strattera, demonstrated effective, continuous relief of core ADHD symptoms including inattention and/or hyperactivity-impulsivity, from morning until late evening. Strattera treats ADHD without causing insomnia in most children. It was also shown to be effective in children who had other co-morbid conditions such as tics and anxiety, and in patients with or without prior stimulant use.

Strattera works differently than other medications approved for the treatment of ADHD. It works by selectively blocking the reuptake of norepinephrine, a chemical messenger, or neurotransmitter, in certain nerve cells in the brain. This action increases the availability of norepinephrine, which is thought to be essential in regulating impulse control, organization and attention.

Strattera, given once or twice daily, will allow children to avoid the stigma associated with school-day dosing. And, as a non-stimulant, it has little or no potential for abuse or drug diversion (where the medication is forwarded on to others for recreational use).

ADHD affects three to seven per cent of school aged children1
ADHD is a biological, brain-based condition thought to be caused by an imbalance of some of the brain's neurotransmitters, which are the substances used to signal between nerve cells.2 The condition is characterized by hyperactive/impulsive behaviours and/or attention-deficit problems that cannot be explained by any other psychiatric condition and are not in keeping with the child's intellectual ability or stage of development.3

ADHD begins in childhood, and is estimated to affect three to seven per cent of school-aged children.1 It is one of the most common disorders of childhood and adolescence.3 Experts estimate that up to 65 per cent of children with the disorder carry their symptoms into adulthood.3

ADHD can have considerable consequences for children, their families and society as a whole. It may lead to impairments in major activities of life and to anti-social behaviour, including academic and vocational difficulties, emotional and social problems.

"With Strattera, we've seen a significant improvement," said Kathryn Noonan whose 11-year old son was diagnosed with ADHD three years ago. "He can now sit still and focus and it's easier for him to make friends, which has helped his confidence and self-esteem," she added.

Strattera studied in major clinical trial program
Strattera has undergone an extensive clinical trial program in children, adolescents and adults with ADHD. More than 6,000 children, adolescents and adults, including more than 200 Canadians, have taken Strattera, some for as long as three years, during completed and ongoing short- and long-term clinical trials. Strattera's primary efficacy has been established in six, randomized, double-blind placebo-controlled registration studies.

Additional double-blind, placebo-controlled studies were also conducted with children and adolescents in the school setting, in an assessment of evening efficacy and in patients with co-morbid tic disorder, and efficacy was established in these studies.
Long-term efficacy of Strattera was further established in an 18-month randomized, double-blind, placebo-controlled relapse-prevention study. In both paediatric and adult studies, Strattera showed efficacy in patients who had been previously treated with stimulants, as well as in stimulant-naive patients (those who had not been treated with stimulants prior to receiving Strattera).

Strattera has demonstrated relief of ADHD symptoms that can result in improvements in quality of life and functioning, including behaviour at school, self-esteem and family functioning.

About Strattera
Strattera was found to be generally safe and well tolerated. Most people in clinical studies who experienced side effects were not bothered enough to stop taking Strattera. The most commonly observed adverse events in placebo-controlled clinical trials in children and adolescents were upset stomach, decreased appetite, nausea, vomiting, dizziness, tiredness, sleepiness and irritability. Strattera can cause liver damage in rare cases. Strattera has not been tested in children less than six years of age.4

Strattera has a gradual onset of action, and the dose needs to be slowly increased to reach an effective maintenance dose as directed by a health care professional. Patients should be maintained at each dose level for a sufficient length of time (at least 10 days) so they can observe if this is an effective dose for treating their symptoms. The dose should then be increased to the next level only if needed, for patients who have not achieved optimal clinical response. It is important that patients do not exceed the recommended initial dose, subsequent dose increases and maximum daily dose. If the dose of Strattera is increased too quickly, there may be increased side effects, such as sleepiness and digestive system complaints. Improvement of ADHD symptoms is generally observed within one to four weeks after starting therapy.4

To date, Strattera has been used by more than two million patients worldwide since it first became available in January 2003. It is currently available in Australia, Argentina, Colombia, Dominican Republic, Mexico, Peru, the United States, the United Kingdom and Venezuela. Strattera is not yet commercially available in Canada, however it is expected to be available by the end of March 2005.

1. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision. Washington, DC, American Psychiatric Association, 2000.2. Green C, Chee K. Understanding ADHD - The Definitive Guide to Attention Deficit Hyperactivity Disorder. The Random House Ballantine Publishing Group 1998.
3. Dulcan M., Dunne JE., Ayres W., et al. Practice Parameter for the Assessment and Treatment of Children, Adolescents and Adults with Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry 1997; 36(10s): 85s-121s.
4. Strattera(tm) Product Monograph. Eli Lilly Canada Inc. December 22, 2004.

Strattera™ is a trademark of Eli Lilly and Company.

SOURCE: Eli Lilly and Company




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