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New Study on ADDerall

SAN ANTONIO, TX -- May 15, 2000

A new study published in this month's Journal of the American Academy of Child and Adolescent Psychiatry found that Adderall(R) (mixed salts of a single-entity amphetamine product) is significantly more effective at reducing inattention, oppositional behavior, and other symptoms of attention deficit/hyperactivity disorder (ADHD) than methylphenidate, an older ADHD treatment.

The study of 58 children with ADHD also found that the benefits of Adderall last longer than those of methylphenidate (which is sold under the brand name Ritalin(R)). In fact, 70 percent of patients taking a single morning dose of Adderall found significant improvement in ADHD symptoms, while just 15 percent of patients taking methylphenidate improved significantly with only one dose.

"In our study, children with ADHD showed more improvement after Adderall treatment compared with methylphenidate," said Steven Pliszka, M.D., lead investigator of the study and chief of child and adolescent psychiatry at The University of Texas Health Science Center at San Antonio. "It is important for children with ADHD to have effective treatment, because left untreated, ADHD can increase the risk of low self-esteem and social and academic failure."

In Dr. Pliszka's clinical study, 58 children diagnosed with ADHD were given Adderall, methylphenidate, or placebo for three weeks in a double-blind parallel-group design. All groups started week one on a once-daily dosing regimen. If the children's afternoon or evening behavior did not improve after week one, a mid-day or 4 p.m. dose was added for week two.

Teachers rated morning and afternoon behaviors, while parents rated evening behaviors. According to teacher ratings, Adderall produced more improvements in inattentive and oppositional behaviors than methylphenidate (p less than 0.05).

In addition, the psychiatrist-administered Clinical Global Impression Improvement scale, which is used to assess response to treatment, showed that more children found greater ADHD symptom relief with Adderall than with methylphenidate. In fact, 90 percent of children taking Adderall were found to be "very much improved" or "much improved" in behavior, when statistically compared with 65 percent of the methylphenidate group and 27 percent of the placebo group (p less than 0.01).

The study also showed that 70 percent of patients taking Adderall and only 15 percent of patients taking methylphenidate were still on once-daily dosing at the end of the study, based on a pre-defined dose titration scheme. "The higher response rate for Adderall is very encouraging," Dr. Pliszka said. "Our study suggests that Adderall can be the first option for the treatment of ADHD."

In the study, both medications were well tolerated, and side effects were similar to placebo. The most common side effects associated with stimulant use are insomnia, loss of appetite, stomach pain, headache, irritability, and weight loss.

The University of Texas study was funded with a grant from Shire Richwood Inc., which manufactures Adderall.

ADHD affects 3 percent to 5 percent of all school-age children, and is considered the most frequently diagnosed psychiatric disorder in children and adolescents. The most common behaviors exhibited by those who have ADHD are inattention, hyperactivity, and impulsivity.

Stimulant medications -- which stimulate areas of the brain that control attention, impulses, and self-regulation of behavior -- are among the most successful treatments for people with ADHD. In fact, at least 70 percent of children with ADHD respond positively to treatment with stimulant medication.

Adderall is a stimulant medication for the treatment of ADHD. It has been shown to improve attention span, decrease distractibility, improve the ability to follow directions and complete tasks, and decrease impulsivity and hyperactivity.

Adderall is generally well tolerated. While adverse reactions are rare, the most frequently reported adverse reactions include anorexia, insomnia, stomach pain, headache, irritability, and weight loss. These side effects are similar to those seen with other stimulant medications used to treat ADHD. As with most stimulant medications indicated for ADHD, the possibility of growth suppression and the potential for precipitating motor tics and Tourette's syndrome exists with Adderall treatment, and, in rare cases, exacerbations of psychosis have been reported. Since all amphetamines have a high potential for abuse, Adderall should be used only as part of a comprehensive treatment program under close physician supervision.

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