To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Attenade Effective In the Treatment Of ADD And ADHD URL: http://www.pslgroup.com/dg/129C2A.htm Doctor's Guide September 9, 1999
WARREN, NJ -- Sept. 9, 1999 -- Initial results of two pivotal efficacy trials for Celgene Corp.'s Attenade(TM) (d-methylphenidate), its chirally-pure version of Ritalin(R) (dl-methylphenidate), for the treatment of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD), show that Attenade is superior to placebo in controlling the symptoms of the disorders. In the trial that included Attenade, dl-methylphenidate and placebo, Attenade exhibited a statistically significant longer duration of action than dl-methylphenidate. Scientific review of these results will be presented at the October meeting of the American Academy of Child and Adolescent Psychiatry. "These initial results are great news for the research into new treatments for this prevalent disorder. The data again confirms the value of Celgene's new drug at half the dose of the most commonly prescribed treatment for ADHD," said Declan Quinn, MD, a child and adolescent psychiatrist with the Royal University Hospital of Saskatoon. "Pending regulatory reviews, this new formulation may be a significant step in the pharmacological treatment of children with ADHD." More than 200 children participated in the multi-centre trials. Both trials compared Attenade to placebo. The second trial directly compared the efficacy of both Attenade and dl-methylphenidate to placebo. The trials demonstrated a statistically significant longer duration of action for Attenade than dl-methylphenidate. In both trials, behavioural and objective measures were examined. Attenade had improved scores over dl-methylphenidate in all parameters measured. The results of the primary efficacy analysis for the first trial indicated that Attenade was significantly more effective than placebo as evaluated by a behavioural scale (Teacher SNAP-ADHD), signifying an improvement in the clinical status of the children. The results of the second trial confirmed the drug's efficacy and duration of action. The trial also demonstrated a statistically significant longer duration of action for Attenade versus dl-methylphenidate as measured by a behavioural scale. The incidence of side effects in the trials was very low. Compared to placebo, both Attenade and dl-methylphenidate were associated with decreased appetite and mild abdominal pain. Full evaluation of the safety profile awaits completion of on-going safety trials early next year. "Surprisingly in both multi-centre studies, our initial hypothesis on the duration of action of Attenade based upon the Phase I/II study was confirmed," said James Swanson, Ph.D., professor of pediatrics, psychiatry and social sciences at UC-Irvine. Dr. Swanson served as primary investigator of the studies. The Journal of the American Medical Association has reported that three to six percent of school-age children (elementary to high school) have ADHD. This condition is characterised by symptoms of inappropriate inattention, hyperactivity and impulsiveness. It estimated that between one and two million children in the U.S. are now being treated for this condition. North American sales of drugs treating these symptoms are estimated to exceed $500 million US per year. Related Links: Ritalin and Celgene Corp.. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.