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11/27/2002

Nonstimulant ADHD Treatment Clears FDA

Kate Traynor

The Food and Drug Administration (FDA) yesterday approved the marketing of atomoxetine hydrochloride, a nonstimulant drug indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.

Eli Lilly & Co. will market the drug under the brand name Strattera. The company said it expects to supply pharmacies with the new product in January.

Atomoxetine is the first FDA-approved ADHD treatment that is not classified as a Schedule II controlled substance, a factor that Lilly expects will ease the process of prescribing and dispensing the product.

The drug has not been tested for use in children under six years of age or in elderly patients. Use of the drug for more than 10 weeks has not been methodically evaluated, and the product's labeling cautions clinicians to periodically reevaluate their patients' status.

Strattera will be supplied in 30-count bottles of capsules containing 10, 18, 25, 40, or 60 mg of atomoxetine. The product can be taken once daily in the morning or twice a day, with the total daily amount split between a morning dose and a late afternoon or early evening dose. Doses can be taken without regard to meals.

The recommended starting dosage for children and adolescents weighing up to 70 kg is 0.5 mg/kg per day. After three or more days, the total daily dose should be increased to 1.2 mg/kg. The labeling does not specify whether to incrementally increase the dosage. Children and adolescents weighing up to 70 kg should receive no more than 100 mg or 1.4 mg/kg, whichever is less, of atomoxetine each day.

For adults and for children and adolescents weighing more than 70 kg, the recommended starting dosage is 40 mg per day, increased after three or more days to a target dosage of 80 mg per day. The total daily dose may be increased to 100 mg, but no higher, after two to four additional weeks if the patient has not responded adequately to the lower dosages.

Dosage adjustments may be necessary in patients with liver disease and in people who are taking a drug, such as paroxetine or fluoxetine, that strongly inhibits the activity of cytochrome P-450 isoenzyme 2D6.

Atomoxetine is contraindicated in patients with narrow-angle glaucoma. The drug is also contraindicated in people who concurrently take a monoamine oxidase inhibitor (MAOI), but atomoxetine can be used if at least two weeks have elapsed since the last dose of the MAOI. Therapy with atomoxetine should likewise be discontinued for two weeks before the use of an MAOI.

In the clinical trials involving children and adolescents, the most common reasons for discontinuing atomoxetine therapy were the development of aggression, irritability, somnolence, or vomiting, each of which occurred in 0.5 percent of patients. Among the adults who participated in the studies, the most common symptoms leading to the cessation of therapy were insomnia, which was reported by 1.1 percent of patients, and chest pain, palpitations, and urinary retention, each reported by 0.7 percent of patients.

According to the product's labeling, atomoxetine apparently exerts its therapeutic effect by selectively inhibiting the presynaptic transport of norepinephrine in the brain, but this finding has not been definitively shown.