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http://www.washingtonpost.com/ac2/wp-dyn/A43588-2002Nov26?language=printer

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FDA Approves ADHD Drug Offering Fewer Side Effects
 

By Shankar Vedantam
Washington Post Staff Writer
Wednesday, November 27, 2002; Page A02

A new type of medicine to treat attention-deficit/hyperactivity disorder (ADHD) was approved yesterday by the Food and Drug Administration, bringing with it the promise that the most common psychiatric disorder of childhood may be treated with fewer side effects -- and less controversy.

Atomoxetine, which will be marketed under the brand name Strattera, will join in January such drugs as Ritalin that are prescribed by physicians. It will become the first medicine to treat ADHD that is not a stimulant.

Early studies have indicated that the new medicine does not cause insomnia, and is generally well tolerated by children, adolescents and adults. No comprehensive studies have compared the effectiveness of the new medicine against the older drugs, so it will be months before clinicians can establish which drug works best for each patient.

An important advantage of the new medicine is that it will be the first drug to treat ADHD that is not listed as a Schedule II drug, meaning that the FDA does not fear it will be abused.

"This is the first medicine for ADHD that works through a mechanism different than the stimulant medicines used for the last 40 years," said Calvin R. Sumner, senior clinical research physician at Eli Lilly & Co. in Indianapolis, the maker of the new drug.

Sumner said Strattera increases the level of norepinephrine, a chemical in the brain that transports signals between nerve cells. Most previous medicines have targeted another neurotransmitter called dopamine; both norepinephrine and dopamine are believed to play a role in ADHD, a disorder characterized by inattention and hyperactivity.

Estimates of the prevalence of ADHD vary between 2 and 7 percent in American children. Several medications and behavioral interventions have been found to be effective against the disorder. Treatment often leads to better performance in schools and better family relationships, doctors say.

Sumner said that the medicine would be taken once a day, and that questions of price were being decided.

As with most psychiatric medicines, Sumner said researchers did not know how the drug produced its benefits. For years, scientists have puzzled over why stimulants increase concentration and reduce hyperactivity in people with ADHD.

E. Clarke Ross, chief executive officer of the patient advocacy group Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD), said that a larger range of treatments, especially with a new class of medicine, was welcomed by families dealing with the disorder.

"It is still going to be important for parents to ask lots of questions and weigh all the risks and benefits of any treatment approach before they decide what's best for their child," said David Fassler, a psychiatrist at the University of Vermont College of Medicine in Burlington, and an authority on children's mental health problems.

"Any treatment has both risks and benefits, and from the early indications this appears to be a safe medication which is well tolerated by children," he said. But we really want to see much more data."

Eli Lilly has unveiled a significant marketing campaign for the new medicine.

Lawrence Diller, author of "Running on Ritalin" and a pediatrician in Walnut Creek, Calif., said he was recently offered $500 to attend a dinner at the Four Seasons Hotel in San Francisco sponsored by Eli Lilly to tell doctors about Strattera.

"The holy grail in treating ADHD is finding a drug that will lead people to be focused without being a stimulant," he said. Strattera "may look a little different and act a little different," but he said head-to-head trials against current medicines are needed.

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