No Benefit Noted From Provigil (Modafinil) In Adult Attention Deficit Hyperactivity Disorder
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No Benefit Noted From Provigil (Modafinil) In Adult Attention Deficit Hyperactivity Disorder

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.

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