Date: November 27, 2002
FDA Approves Atomoxetine*, First Non Stimulant Option
For Treatment of Attention-Deficit/Hyperactivity Disorder
First New Class of ADHD Medication in Decades Gives
Families, Physicians a New Choice
The U.S. Food and Drug Administration (FDA) approved atomoxetine hydrochloride last night, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults.
Atomoxetine, developed by Eli Lilly and Company (NYSE:LLY), is the first FDA-approved treatment for ADHD that is not a stimulant under the U.S. Controlled Substances Act. Atomoxetine has also been submitted for regulatory approval in Australia, New Zealand, and Canada, and Lilly hopes to submit for approval in Europe within the next 12 months.
The efficacy of atomoxetine in the treatment of child, adolescent and adult patients with ADHD, has been investigated in six placebo-controlled clinical studies. So far, more than 4,000 patients have taken atomoxetine in all of the completed and ongoing clinical trials, some for as long as two and a half years.
Dr Joanne Barton, Consultant Child and Adolescent Psychiatrist, Department of Child & Adolescent Psychiatry, University of Glasgow, who is one of the principle investigators conducting trials in atomoxetine in the UK has stated, "The granting of this license by the FDA represents a real therapeutic advance in the overall management of children with ADHD because it's the first non-stimulant drug treatment and the first new type of medication for the treatment of ADHD to be approved anywhere in the past thirty years. From a clinical perspective, this compound is really an exciting development because it may provide full-day relief of ADHD symptoms without causing insomnia in majority of children and adolescents."
According to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, ADHD affects 3-7 percent of school age children. In the UK it is currently diagnosed in less than 1 per cent of children2 and therefore many children with ADHD are not receiving behavioural, psychological or medical treatment. ADHD manifests itself in levels of attention, concentration, activity, distractibility and impulsivity that are inappropriate for the child's age.1 A growing body of evidence suggests a biological cause and a genetic link for the disorder, and experts estimate up to 65 percent of children with the disorder continue to have symptoms as adults.1,3
"Left untreated, ADHD can have a significant negative and long-term impact on all aspects of the lives of the individuals and their families. It adversely impacts on an individual's social, family and occupational functioning, which can have devastating consequences. I am also delighted that the license in the US includes adults. This is the only medication that is licensed for use in adults with ADHD, and will therefore help with the recognition that ADHD is a life long condition, not just limited to childhood. This is something that needs to be stressed more in the UK," said Andrea Bilbow, founder of ADDISS (the National Attention Deficit Disorder Information and Support Service).
Delays of up to several years in diagnosing and treating ADHD create significant burdens on individuals with the disorder, their families and society.4 The data indicate that individuals with ADHD who have not received an appropriate diagnosis and treatment may experience problems such as academic difficulties, trouble forming close friendships and participating in social activities.
How atomoxetine works
Atomoxetine, a selective norepinephrine reuptake inhibitor, has a different pharmacologic mechanism than other currently approved ADHD treatments. It's not known precisely how atomoxetine reduces ADHD symptoms. Scientists believe it works by blocking or slowing reabsorption of norepinephrine, a brain chemical considered important in regulating attention, impulsivity and activity levels.5 This keeps more norepinephrine at work in the tiny spaces between neurons in the brain.
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 were decreased appetite, nausea, vomiting, tiredness and upset stomach. In adults, the most common side effects were problems sleeping, dry mouth, decreased appetite, upset stomach, nausea or vomiting, dizziness, problems urinating, and sexual side effects.
"Atomoxetine is an important development in the treatment of ADHD, and we are excited about its future," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "It may give patients, families and physicians an effective new tool for treating this complicated disorder and illustrates Lilly's commitment to providing 'Answers That Matter.'
The approval came roughly three months after the FDA issued an approvable letter for atomoxetine. Lilly expects to have atomoxetine available in U.S. pharmacies in January.
Atomoxetine should not be taken at the same time as, or within two weeks of taking, a monoamine oxidase inhibitor 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 under 6 years of age. Some children may lose weight when starting treatment with atomoxetine. As with all ADHD medications, growth should be monitored during treatment.
About Eli Lilly and Company
Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of 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.
This news release contains forward-looking statements that reflect management's current beliefs about the potential for atomoxetine in the treatment of attention-deficit/hyperactivity disorder (ADHD). There are no guarantees that the product will prove to be commercially successful. The company's results may also be affected by such factors as competitive developments affecting current growth products, the rate of growth of the company's key products, the timing of anticipated regulatory approvals and launches of new products, regulatory developments involving current and future products and manufacturing facilities, the impact of governmental actions regarding coverage and reimbursement for pharmaceuticals, and the impact of exchange rates. For additional information about the factors that affect the company's business, please see Exhibit 99 to the company's latest Form 10-Q, filed November 2002 with the US Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements.
*Atomoxetine hydrochloride will be marketed in the U.S. under the tradename Strattera™.
1 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, Washington, DC, American Psychiatric Association, 2000.
2 NICE Technology Appraisal Guidance - No. 13. Guidance on the use of methylphenidate (Ritalin, Equasym) for Attention Deficit/Hyperactivity Disorder (ADHD) in childhood. October 2000.
3 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 (10): 85S-119S
4 SJ Ralston et al., 'ADHD has a significant burden upon the individual, family and society in Europe,' presented at 15th European College of Neuropsycopharmacology Congress - October 7, 2002, Barcelona, Spain
5 Bymaster, Frank P. et al, 'Atomoxetine Increases Extracellular Levels of Norepinephrine and Dopamine in Prefrontal Cortex of Rat,' Neuropsychopharmacology, 7 November 2002: Volume 27/5, pp. 699-711.