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FDA Approves Non-Stimulant ADHD Drug-- Strattera (Atomoxetine)

BETHESDA, MD -- December 2, 2002 -- The Food and Drug Administration has approved -- Strattera, (atomoxetine) -- the first new drug in three decades for treatment of symptoms of attention deficit hyperactivity disorder, or ADHD, which includes inattention, hyperactivity and impulsiveness. Strattera has a different mechanism of action from the stimulant-like drugs that have been used to treat ADHD. Because Strattera does not appear to have a potential for abuse, it will not be classified as a controlled substance, although it will be a prescription drug.

According to the American Psychiatric Association, about three to seven percent of children have attention deficit hyperactivity disorder. It is estimated that about four percent of adults have ADHD. People with ADHD may make careless mistakes, fidget, interrupt others, talk excessively and have problems paying attention. Symptoms must be persistent, that is, be present for at least six months, and must be more severe than is typically observed in individuals at a comparable level of development before a diagnosis can be made with certainty, according to the Diagnostic and Statistical Manual (DSM-IV), the diagnostic manual for psychiatric disorders, published by the American Psychiatric Association. Although the disorder is not as well defined in adults, symptoms in adults may include a lack of organization, daydreaming, irritability, and lack of motivation.

Strattera was studied in children, adolescents and adults. The drug's safety and effectiveness were established in six double-blind placebo-controlled studies in patients who met specific diagnostic criteria under DSM-IV. The clinical studies demonstrated that Strattera significantly improves patient's symptoms compared to placebo.

Side effects of the drug include decreased appetite, upset stomach, nausea or vomiting and tiredness. In addition to these adverse effects, some of the most common side effects in adults were problems sleeping, dry mouth, dizziness, and sexual side effects.

The drug will be marketed by Eli Lilly and Company, Indianapolis, Ind.

SOURCE: FDA

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