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| |  AAN: Concerta (methylphenidate HCl) ER improves attention, behaviour in ADD/ADHD SAN DIEGO, CA -- May 5, 2000 -- ALZA Corporation announced the presentation of clinical results of Concerta(TM) (methylphenidate HCl) extended-release tablets (CII) in the treatment of children with Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD). The results were presented at the American Academy of Neurology's (AAN) 52nd Annual Meeting in San Diego, California. 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 day, eliminating the need for in-school and after-school dosing. Two-hundred and six children between the ages of six and 12 with a clinical diagnosis of ADHD completed the multicenter study presented at AAN. Patients were randomized to one of three blinded treatments for a period of 28 days, and were either treated with Concerta once daily, immediate-release methylphenidate three times daily or placebo. The children were evaluated by multiple raters including behavioral specialists, teachers and parents in multiple settings using standardized tests for behavior and attention. An assessment of children's behavior was recorded using the Inattention/Overactivity with Aggression (IOWA) Conners measurement scale, which ranked behavior on a scale of 0 to 15, with higher ratings reflecting higher degrees of inattention and overactivity. Based on this measurement, a significant improvement in attention and behavior was shown for Concerta and conventional methylphenidate when compared with placebo (p<0.001). At final assessment, patients taking Concerta, methylphenidate and placebo had scores of 5.98, 6.35 and 9.77, respectively, as rated by teachers. Parents provided similar ratings. "In this study, Concerta was effective throughout the day, including the late afternoon when children participate in extra-curricular activities and spend time with their families. This is an important outcome, since children with ADHD often display symptoms during these times," said Laurence Greenhill, M.D., a child psychiatrist at the New York State Psychiatric Institute (NYSPI) and Professor of Clinical Psychiatry at the Columbia College of Physicians and Surgeons, who was one of the investigators participating in this multi-center study. In the study, once-daily Concerta had a similar safety profile to methylphenidate given three times daily. Adverse events related to treatment that occurred in more than 2 percent of patients taking Concerta include headache (9.6 percent), abdominal pain (4.8 percent), decreased appetite (3.8 percent), insomnia (2.9 percent) and vomiting (2.9 percent). Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder is characterized by symptoms of inappropriate inattention, hyperactivity and impulsiveness. ADD/ADHD is the most common psychiatric disorder in children, according to the American Psychiatric Association. ALZA Corporation, headquartered in Mountain View, California, 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 currently focused in urology and oncology, and are expanding into the central nervous system area. Related Link: ALZA Corporation.
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