Magazine article Clinical Psychiatry News

Nonstimulant Atomoxetine Approved for ADHD. (Distribution Will Be Easier)

Magazine article Clinical Psychiatry News

Nonstimulant Atomoxetine Approved for ADHD. (Distribution Will Be Easier)

Article excerpt

Adults and children suffering from attention-deficit hyperactivity disorder now have a treatment specifically indicated for them.

Atomoxetine (Strattera), a nonstimulant, is the first drug to receive Food and Drug Administration approval for the treatment of attention-deficit hyperactivity disorder (ADHD) in both adults and children. It is also the first new type of drug approved for the disorder in 3 decades.

Data from six double-blind trials presented to the FDA--with 697 patients taking atomoxetine, 427 of whom were children and adolescents-found the drug to be significantly more effective than placebo.

As a nonstimulant, atomoxetine dodges a controlled substances classification, unlike stimulant medications now prescribed for ADHD. This will make it more convenient for physicians to distribute samples and to phone in prescriptions and refills to pharmacies. And it may also improve compliance. The drug is not classified as a controlled substance because it does not appear to have a potential for abuse, according to several physicians at a teleconference sponsored by the manufacturer of atomoxetine, Eli Lilly & Co.

Atomoxetine, which comes in capsule form, can be taken once or twice a day, although much is made of its single-dosing potential.

"[Medication] coverage throughout the day is a good fit for an active adult with ADHD, and the lack of scheduling can increase compliance," Dr. Lenard Adler of New York University said during the teleconference. Dr. Adler participated in clinical trials funded by Eli Lilly.

Yet little research has been done using a single daily dose. Of the six double-blind, placebo-controlled studies presented to the FDA, only one used the single dose, and it was limited to children.

Both of the 10-week studies with patients 18 years and older used a divided dose in the morning and again late in the afternoon. Those studies-involving 270 adult patients who received atomoxetine-did show a significant improvement in symptoms for those on atomoxetine, compared with those on placebo.

Atomoxetine appears to work through a different mechanism than other treatments. "That's the really exciting thing about it," said Dr. Thomas Spencer of Harvard University, who also participated in clinical trials sponsored by Eli Lilly. It is a selective norepinephrine reuptake inhibitor. The exact mechanism is unknown, but scientists speculate that it works by slowing the reuptake of norepinephrine, which regulates attention, impulsivity, and activity levels in the brain.

Stimulant drugs--such as methyl-phenidate (Ritalin, Concerta, Metadate, and Methylin)-remain the preferred method to date for treating ADHD, Dr. …

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