Largest-Ever ADHD Trial Shows ADDERALL XR(R) Safely And Effectively Improves ADHD Symptoms And Improves Quality Of Life In Children With The Disorder

Market Wire, 20050229

Results from the largest-ever ADHD (attention deficit-hyperactivity disorder) clinical trial show that ADDERALL XR(R) (mixed salts of a single-entity amphetamine product), a once-daily extended-release ADHD medication, significantly improves the hallmark symptoms of ADHD and the quality of life of children living with the condition. Quality-of-life assessments show significant improvements in social relationships with friends and family, as well as scholastic, emotional, and physical functioning of the child. The study, known as LADD.CAT, involves nearly 3,000 children with ADHD, and was presented today at the 14th Annual CHADD (Children and Adults with Attention-Deficit Hyperactivity Disorder) International Conference on ADHD in Miami.

The study showed that both the children's parents as well as their physicians were satisfied with ADDERALL XR and preferred the medication by a significant margin to their previous ADHD medication regimens. Children in LADD.CAT (which stands for Long-Acting Adderall Community Assessment Trial) previously were taking either immediate-release ADDERALL(R) or a methylphenidate formulation, such as Ritalin(R) or Concerta(R), and were switched to ADDERALL XR.(1)

"ADHD is an all-day disorder that requires treatment to manage symptoms at home, in school, and in social settings. This large-scale study is important because it demonstrates ADDERALL XR can be administered safely and is effective in the real-world setting," said the study's lead investigator, Paul J. Ambrosini, M.D., Professor of Psychiatry at MCP Hahnemann University. "ADDERALL XR helps children improve their functioning, such as getting along with other children, paying attention in class, and completing tasks. This translates into a positive impact not only on the child but also on his or her family."

LADD.CAT also demonstrated the safety of ADDERALL XR. Most adverse events were mild or moderate. The medication had no significant impact on weight in children during the course of the study. The most frequently reported adverse events were headache, insomnia, decreased appetite, and abdominal pain.

About LADD.CAT

LADD.CAT is a phase IIIb, open-label, community assessment, 7-week study (with an 8-week extension) involving 2,968 children with ADHD (ages 6-12) in 378 sites in the United States, conducted between June and December 2001. Depending on the dose, type, and frequency of ADHD medication they previously were taking, children received a starting dose of 10 mg, 20 mg, 30 mg, or 40 mg of ADDERALL XR, administered once a day. They were titrated up (to a maximum of 40 mg) or down, if necessary, to achieve symptom control and minimize side effects. Children were evaluated 8 and 12 hours post-dose at weeks 1, 3, and 7.

Study results include:

-Parent Evaluation -- The Conners' 10-item Global Index Scale - Parent version (CGIS-P) was used to measure improvement in ADHD symptoms. The lower the CGIS-P score, the more improvement seen in symptoms of ADHD.

After switching to ADDERALL XR, ADHD symptoms in patients improved significantly. Compared to symptom levels on previous treatment regimens, there was a statistically significant improvement in the mean CGIS-P scores at week 7. On previous treatments, the mean CGIS-P score was 10.2 at 8 hours post dose and 11.7 at 12 hours post dose; at week seven, ADDERALL XR treatment produced a score of 5.4 at 8 hours (P < 0.0001) and 7.4 at 12 hours (P < 0.0001). These findings were consistent with the highly significant results of the key ADDERALL XR registration studies.

-Physician Evaluation -- The Clinical Global Impression (CGI) Scale, a global evaluation of improvement over time rated by a clinician, demonstrated that 60 percent of children were much improved or very much improved at week 7 on ADDERALL XR compared to their previous treatment regimen.

-Quality of life measurements - The PedsQL(TM) Scales, completed by the same parent or caregiver for each child, are designed to measure the core dimensions of physical as well as emotional, social, and school functioning. On previous treatment regimens the PedsQL total score (physical health and psychosocial health) was 74.5, and improved to a score of 81.0 at week 7 on ADDERALL XR (P < 0.0001).

-In a parent satisfaction survey, 50 percent of parents strongly agreed they were satisfied with ADDERALL XR at the end of the study. This compares to 18 percent of parents who strongly agreed they were satisfied with their child's previous treatment at the beginning of the study.

-In parent and physician preference surveys, ADDERALL XR was shown to be the preferred treatment, compared with previous treatment regimens taken. For parents surveyed, 83 percent preferred ADDERALL XR treatment for their children vs. 9 percent who preferred the previous treatment regimens. For physicians, 88 percent preferred ADDERALL XR treatment for their patients vs. 6 percent who preferred the previous treatment regimens.

The study was supported by Shire Pharmaceutical Development Inc.