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First New Class of ADHD Medication in Decades Gives Families, Physicians a New Choice
November 26, 2002 -- The U.S. Food and Drug Administration (FDA) today approved Strattera ™ (atomoxetine HCl), judging it safe and effective for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents and adults.
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Strattera, developed by Eli Lilly and Company, is the first FDA-approved treatment for ADHD that is not a stimulant under the Controlled Substances Act. Having a noncontrolled option, such as Strattera, reduces prescription hassles for patients, families and physicians by offering the convenience of phone-in refills and samples. Strattera is also believed to be a less likely candidate for abuse by patients than other attention deficit drugs because it is the only FDA-approved treatment for the disorder that is not a stimulant.
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"Strattera 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 gives patients, families and physicians an effective new tool for treating this complicated disorder."
The approval came roughly three months after the FDA issued an approvable letter for Strattera. Lilly expects to have Strattera available in pharmacies in January.
Lilly demonstrated Strattera's effectiveness in treating ADHD with data from six placebo-controlled clinical studies, involving children, adolescents and adults. So far, more than 4,000 patients have taken Strattera in all completed and ongoing clinical trials, some for as long as two-and-a-half years. Strattera comes in a capsule and can be taken once or twice a day. Strattera is the first ADHD medication proven clinically effective in adults.
"Strattera is unique, because of its different mechanism of action for ADHD; it's the first noncontrolled medication indicated for the treatment of ADHD. It provides full-day relief of ADHD symptoms without causing insomnia in most children and adolescents," said Thomas J. Spencer, M.D., associate professor of psychiatry, Harvard Medical School, and assistant chief, Pediatric Psychopharmacology Research Program, Massachusetts General Hospital. Dr. Spencer is one of the initial investigators to conduct clinical trials with Strattera.
Strattera, a selective norepinephrine reuptake inhibitor, works differently than any other FDA-approved ADHD treatments. It's not known precisely how Strattera 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. This keeps more norepinephrine at work in the tiny spaces between neurons in the brain.
Strattera 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 Strattera. Strattera has not been tested in children less than 6 years of age. Some children may lose weight when starting treatment with Strattera. As with all ADHD medications, growth should be monitored during treatment.
Most people in clinical studies who experienced side effects were not bothered enough to stop using Strattera. 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.
ADHD affects 3-7 percent of school age children, making it the most-commonly diagnosed behavioral disorder of childhood. It manifests itself in levels of attention, concentration, activity, distractibility and impulsivity that are inappropriate for the child's age. A growing body of evidence suggests a biological cause and a genetic link for the disorder, and experts estimate up to 60 percent of children with the disorder continue to have symptoms as adults.
"Left untreated, ADHD can have significant negative consequences, and not just at school or work. It also affects social and family situations, as well as self-worth," Dr. Spencer said.
Although ADHD in adults is not widely recognized, experts estimate 4 percent of adults, more than 8 million people, have the disorder. Most adults with ADHD go undiagnosed and/or untreated, in part because it is perceived as a childhood disorder, and in part because of concerns about giving controlled substances to adults.
"Adults with ADHD tend to have lower rates of professional employment, more frequent job changes and lower self-esteem. These serious consequences, both personal and professional, highlight the need for effective treatment of the disorder," said Lenard Adler, M.D. Dr. Adler is a psychiatrist and director of the Department of Neurology, Attention Deficit Hyperactivity Disorder Program, and associate professor of clinical psychiatry and neurology at the New York University School of Medicine.
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