To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: No Benefit Noted From Provigil (Modafinil) In Adult Attention Deficit Hyperactivity Disorder URL: http://www.pslgroup.com/dg/1DB532.htm Doctor's Guide July 31, 2000
WEST CHESTER, PA -- July 31, 2000 -- Cephalon, Inc. announced that a clinical study of Provigil® (modafinil) Tablets [C-IV] in adults with attention deficit hyperactivity disorder (ADHD) showed that compared to placebo Provigil therapy showed no benefit in reducing the symptoms of ADHD, as measured by the DSM-IV ADHD Rating Scale. The 113-patient, double-blind, placebo-controlled trial compared the safety and efficacy of 100 mg and 400 mg doses of Provigil to a placebo. Provigil was generally well-tolerated. Cephalon chairman and chief executive officer Frank Baldino, Jr., Ph.D., stated: "While we are disappointed with the results of this study, we feel fortunate that three out of four studies with Provigil reported this year -- excessive sleepiness associated with obstructive sleep apnea and shift work and fatigue associated with multiple sclerosis -- have been positive. The company is on plan to pursue label expansion of Provigil in the areas of excessive sleepiness and fatigue. In the meantime, Provigil prescriptions have been growing steadily this year and interest among clinicians in evaluating the drug for other indications is high." Provigil is marketed in the United States, the United Kingdom, Austria, Ireland and Italy for the treatment of narcolepsy or the excessive daytime sleepiness associated with narcolepsy. The drug was approved by the Food and Drug Administration in 1998 as a once-a-day therapy to improve wakefulness in patients experiencing excessive daytime sleepiness associated with narcolepsy. The most frequently reported adverse events observed in clinical trials for narcolepsy were headache, nausea, nervousness, anxiety, infections and insomnia. Related Links: Provigil (modafinil) and Cephalon, Inc. --------------------------------------------------------------------------------------------- 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.