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| |  APA: Study Confirms Long-Term Effectiveness, Safety Of Concerta (Methylphenidate HCl) In Children With ADHD Longer-Term Study Counters Some Long Standing Beliefs About Stimulant Medication PHILADELPHIA, PA -- May 21, 2002 -- One of the longest studies to date of continued use of a stimulant medication confirms the long-term efficacy and safety of Concerta ® (methylphenidate HCl) Cll in children with attention deficit/hyperactivity disorder (ADHD). Results of the longer-term study demonstrate that Concerta effectively controls ADHD symptoms and maintains a consistent safety profile over time. The findings were presented today at the 155th Annual Meeting of the American Psychiatric Association (APA). "While it is generally agreed that pharmacological treatment of ADHD may be needed for extended periods, there is a paucity of long-term data on stimulant medication use," said Timothy Wilens, M.D., associate professor of psychiatry, Harvard Medical School. "This study establishes the safety and efficacy of Concerta over nearly two years, and addresses concerns about the effects of long-term methylphenidate treatment on growth (height and weight), tics, vital signs, and laboratory studies." About the Study Subjects were assigned to one of three daily dosing levels of Concerta (18, 36, or 54mg), taken once a day. Doses could be adjusted among the three levels if considered appropriate by the investigator and participants were permitted to stop taking the medication for weekends or non-school days, or to have medication holidays. Similar to findings observed after 12 months of treatment, the efficacy of Concerta in controlling the symptoms of ADHD was maintained throughout the extended study. "Concerta minimizes the ups and downs ADHD patients often experience with immediate release stimulant medications taken several times a day," explained Dr. Wilens. "The OROS preparation is designed to release the medication in Concerta in a smoothly delivered pattern maintaining improved attention and behavior through 12 hours, including during activities outside of school or work." Children's ADHD-related behavior in school and at home were rated at various intervals of the longer-term study by parents and teachers, using established tools such as the IOWA Conners Ratings Scale. Analysis of responses to a Parent Satisfaction Questionnaire completed at the end of treatment showed that parents were "very satisfied" with Concerta. Concerta was also well tolerated by patients throughout the 21-month study. Investigators reported that Concerta did not adversely affect growth (weight and height); did not appear to worsen or induce tics; did not adversely affect vital signs (i.e., blood pressure, pulse); and had no on effect on a wide range of blood tests (i.e., red and white blood cell count, liver function tests). "These findings add to the literature in countering some long-standing beliefs about the effect of methylphenidate, the active ingredient in Concerta, as a long-term ADHD treatment," noted Dr. Wilens. "The data clearly demonstrates the safety of Concerta up to two years." The type and frequency of adverse events in this study were consistent with the known safety profile of methylphenidate. There were no unusual or unexpected adverse events. About Concerta® Concerta should not be taken by patients who: have significant anxiety, tension, or agitation, since Concerta may make these conditions worse; are allergic to methylphenidate or any of the other ingredients in Concerta; have glaucoma, an eye disease; have tics or Tourette's syndrome, or a family history of Tourette's syndrome; are taking a prescription monoamine oxidase inhibitor (MAOI). Concerta should not be administered to patients with preexisting severe gastrointestinal narrowing. Concerta should not be used in children under six years, since safety and efficacy in this age group have not been established. Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence. (See Boxed Warning in the full U.S. Prescribing Information for Concerta). Concerta was approved by the U.S. Food and Drug Administration in 2000. It is marketed in the United States by McNeil Consumer & Specialty Pharmaceuticals. For more information about Concerta, call 1-888-440-7903 or visit http://www.concerta.net .
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