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| |  APA: Provigil (Modafinil) Reduced Attention Deficit/Hyperactivity Disorder Symptoms WEST CHESTER, PA -- May 18, 2000 -- A study, presented at the annual meeting of the American Psychiatric Association (APA) in Chicago, described the effects of modafinil and the drug's potential as a treatment for Attention Deficit Hyperactivity Disorder (ADHD). The study conducted by Fletcher B. Taylor, M.D., of Tacoma, WA, compared modafinil to dextroamphetamine, a commonly used amphetamine, and placebo in adults with ADHD. Results of the study demonstrated that an average daily dose of approximately 200 mg of modafinil produced a statistically and clinically significant reduction (30 percent or more) in the symptoms of ADHD as measured by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) ADHD Behavior Checklist for Adults, compared to placebo. Modafinil is marketed as Provigil® (modafinil) Tablets [C-IV] in several countries, including the United States, by Cephalon, Inc. for the treatment of excessive daytime sleepiness associated with narcolepsy. The double-blind, placebo-controlled, cross-over study included 22 adult patients meeting the DSM-IV diagnostic criteria for ADHD. In this study, dextroamphetamine at an average daily dose of approximately 20 mg also reduced the symptoms of ADHD with an effect similar to that of modafinil. Both medications were well tolerated. Compared to placebo, the most commonly reported side effects for both modafinil and dextroamphetamine were insomnia, irritability, muscle tension and appetite suppression. Dr. Taylor indicated that he and his colleagues initiated the study because some of their patients wanted an alternative therapy. Today, stimulants, including amphetamine, methylphenidate and pemoline are the most established treatments for ADHD. Treatment of ADHD with traditional stimulants is often associated with troublesome side effects, tolerance and the potential for abuse. In addition, some patients do not respond to currently available therapies. According to Dr. Taylor, "Modafinil, with its low potential for abuse, may represent a valuable treatment option for adults with ADHD." ADHD affects an estimated 5 to 7 million adults and children in the United States. Dr. Taylor noted that while 30 to 70 percent of children with ADHD will retain the diagnosis through adulthood, in his study 70 percent of the participants had a relative with ADHD, usually their child. "We are pleased by the results of this independent study and hope to corroborate these findings with data from our own studies in adults with ADHD," stated Frank Baldino, Jr., Ph.D., chairman and chief executive officer of Cephalon. Cephalon currently is conducting studies with Provigil in adults with ADHD at seven academic medical centers in the United States. In addition, Cephalon has initiated a pharmacokinetic study and intends to initiate a dose-ranging study in children by mid-year, as a prelude to a Phase 3 study in children with ADHD. Provigil was approved by the Food and Drug Administration (FDA) in December 1998 as a once-a-day therapy to improve wakefulness in patients experiencing excessive daytime sleepiness due to narcolepsy. The most frequently reported adverse events observed in clinical trials for narcolepsy were headache, nausea, nervousness, anxiety, infections and insomnia. Cephalon, Inc., headquartered in West Chester, Pennsylvania, is an international biopharmaceutical company dedicated to the discovery, development and marketing of products to treat neurological disorders, sleep disorders and cancer. Related Links: Provigil (modafinil) and Cephalon, Inc.
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