New ADHD medication a promising option

When atomoxetine reaches pharmacies next month, it will be the first noncontrolled drug in 30 years approved by the FDA for treating the disorder.

By Susan J. Landers, AMNews staff. Dec. 23/30, 2002. Additional information

Washington -- Physicians are awaiting with interest the arrival of a newly approved drug to treat attention-deficit/hyperactivity disorder.

On Nov. 26 the Food and Drug Administration approved atomoxetine, which will be marketed as Strattera, as the first new drug in 30 years to treat the disorder that affects 3% to 7% of children and 4% of adults in the United States.

"It certainly is helpful to have a variety of medications available to treat conditions such as ADHD," said David Fassler, MD, a child and adolescent psychiatrist in Burlington, Vt.

Atomoxetine appears to be both safe and effective in the studies that have been presented and published, said Dr. Fassler. But the new drug will be in competition with medications that are backed by decades of experience and hundreds of studies, he noted.

However, atomoxetine does enter the market with one possible advantage over the other drugs now prescribed to treat ADHD. It will be the first noncontrolled option for the treatment of the disorder.

The more traditional treatment options, methylphenidate, dextroamphetamine and amphetamine (marketed as Ritalin, Dexedrine and Adderall) are stimulants and are classified as controlled substances.

3% to 7% of U.S. children and 4% of adults have ADHD.

Since atomoxetine is not controlled, physicians will be able to write prescriptions for longer than a month at a time, and they will also be able to distribute samples.

Lengthier prescribing periods are an advantage for physicians and for families, said James Perrin, MD, professor of pediatrics at Harvard Medical School, "especially for the child who is pretty stable, who is doing fine and needs to be seen and monitored maybe two or three times a year."

Atomoxetine, like some formulations of the other drugs prescribed for ADHD, needs to be taken only once a day, thus saving a child from a mid-day lineup at school to receive additional doses. "It's really a way of keeping children much more involved with their classmates, doing the same things everyone else does," said Dr. Perrin. "It helps diminish the feeling of stigmatization."

Norepinephrine's role

The new medication was developed by Eli Lilly and Co. and is expected to reach pharmacies in January 2003.

The company tested atomoxetine in six placebo-controlled studies involving children older than 6, adolescents and adults, according to Lilly. So far, 4,000 patients have taken the drug, some for as long as 2 1/2 years, according to company literature.

Atomoxetine is a selective norepinephrine reuptake inhibitor, and exactly how it reduces the symptoms of ADHD is not clearly understood. Researchers speculate that it works by blocking or slowing reabsorption of norepinephrine, thus keeping more of the brain chemical at work in the spaces between the neurons.

The newly approved drug only needs to be taken once a day.

Norepinephrine helps regulate attention, impulsivity and activity levels. Disturbances of all three are hallmarks of ADHD. Children with the disorder can't stay focused on a task or even sit still. They often act without thinking and rarely finish projects.

If untreated, the disorder can have long-term effects on a child's ability to make friends or to do well in school. Over time, children with ADHD may develop depression, poor self-esteem and other emotional problems. ADHD frequently persists into adolescence and adulthood, causing continuing problems in maintaining personal relationships and employment.

"It is my hope that the attention that will surround the release of atomoxetine will increase public awareness and recognition of the condition," said Dr. Fassler.

The fact that atomoxetine has been found to be effective for treating ADHD in adults is also likely to prove helpful, he added.

"We used to think that ADHD went away in most people as they grew up. We now find that as many as half of all children and adolescents with ADHD will continue to have problems into adulthood. So we are recognizing and treating more and more of these problems in adults," said Dr. Fassler.

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