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| |  PAS/AAP: Extended Release Concerta (Methylphenidate) As Effective as More Frequent Dosing BOSTON, MA -- May 15, 2000 -- ALZA Corporation announced the presentation of clinical results of Concerta™ (methylphenidate HCl) extended-release tablets (CII) in the treatment of children with attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD). Researchers from the University of California at Irvine presented results of a study that demonstrated once-daily Concerta is superior to placebo and similar in efficacy to methylphenidate given three times a day for the treatment of ADHD. These results were presented at the first joint meeting of the Pediatric Academic Societies and the American Academy of Pediatrics Academic Societies in Boston, Massachusetts. Concerta, which is being developed by ALZA on behalf of Crescendo Pharmaceuticals Corporation, is currently under review for marketing approval by the U.S. Food and Drug Administration (FDA) as a once-daily treatment for ADD/ADHD. Concerta utilizes ALZA's OROS(R) osmotic controlled-release technology to deliver methylphenidate throughout the school day, eliminating the need for in-school and after-school dosing. "This study demonstrated that Concerta taken once-a-day provided consistent improvement in the symptoms of ADHD from the morning through the early evening, and was similar in effectiveness to methylphenidate taken three times a day every four hours," said James Swanson, Ph.D., Director of the Childhood Development Center and Professor of Pediatrics and Cognitive Sciences at University of California at Irvine, and lead investigator for the study. "For children diagnosed with ADHD, multiple daily doses of methylphenidate is inconvenient. Concerta may help improve compliance because it is taken once a day." Concerta has a uniquely patterned plasma profile that minimizes the peak-trough fluctuations associated with methylphenidate given three times a day. This delivery pattern is designed to extend the duration of effect, provide consistent improvement in symptoms and overcome the need for repeated administration throughout the day. In a previous study, blood levels of medication were assessed throughout the day once a week. "We saw smooth plasma concentrations with Concerta without the peaks and valleys in blood levels seen in MPH given three times a day," said Dr. Swanson. The double-blind, randomized placebo-and active-controlled crossover study evaluated 64 children, aged six to 12 years old with a confirmed diagnosis of ADHD who were currently being treated with methylphenidate. Children received each of three treatments (Concerta once a day, MPH three times a day or placebo) for seven days. Over the three-week period, patients were observed in their usual community school five days a week and in a laboratory school setting one day a week. Efficacy was evaluated in multiple settings including community and laboratory schools by both teachers and parents using standardized tests including Inattention/Overactivity with Aggression (IOWA) Conners Inattention/Overactivity (I/O) subscale, which was the primary outcome measure. The sum of the five IOWA Conners I/O subscale items range from zero to 15, with higher ratings reflecting higher degrees of inattention and overactivity. The IOWA Conners I/O subscale scores from the community school teachers showed a significant improvement for Concerta (6.54) and MPH tid (6.89) compared to placebo (11.6), but no significant difference between the two active treatments. Laboratory school teachers used the SKAMP rating scale to measure eight attention items and five behavior items scores nine times throughout the day. SKAMP scores revealed that the onset of action and duration of efficacy were comparable for Concerta and MPH tid. In addition, parents showed a preference for Concerta over the other treatments in the study and over therapy received prior to the study. The study design ensured that all patients received treatment three times a day for all treatment sequences. Thus, these results do not reflect preferences that may result from different daily dosing schedules. "We surmise parents preferred Concerta based on the extent of symptom improvement versus the other treatments," remarked Dr. Swanson. In the study, Concerta was well tolerated and had a similar safety profile to methylphenidate dosed three times daily. Adverse events that occurred in more than 2 percent of patients include headache (4.8 percent), abdominal pain (4.8 percent) and fever (4.8 percent). Attention Deficit Hyperactivity Disorder is characterized by symptoms of inappropriate inattention, hyperactivity and impulsiveness. ADHD is the most common psychiatric disorder in children affecting 3 to 5 percent of all school-aged children, according to the American Psychiatric Association. ALZA Corporation, headquartered in Mountain View, Calif., is a research-based pharmaceutical company with leading drug delivery technologies. The company applies its delivery technologies to develop pharmaceutical products with enhanced therapeutic value for its own portfolio and for many of the world's leading pharmaceutical companies. ALZA markets products developed by ALZA and products licensed or acquired from third parties. ALZA's sales and marketing efforts are focused in urology and oncology and are expanding into the central nervous system area. Related Link: ALZA Corporation.
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