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Studies demonstrate Provigil improves symptoms of ADHD in children

May, 2003 -- Data from two, double-blind, placebo-controlled Phase two studies presented at the 156th Annual Meeting of the American Psychiatric Association show that Provigil (modafinil) C-IV improves attention deficit/hyperactivity disorder (ADHD) symptoms in children in both school and home settings.

These Phase two studies also showed that Provigil was well-tolerated with different dose regimens.

"Preclinical studies suggest that Provigil works selectively through the sleep/wake centers to activate the cortex of the brain. Based on its unique mechanism of action and well-tolerated safety profile, Provigil may represent a different way to treat ADHD in children," said Joseph Biederman, MD, Chief, Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General, Professor of Psychiatry, Harvard Medical School, and one of the lead investigators for the studies.

Provigil is the first in a new class of wake-promoting agents believed to work selectively through the sleep/wake centers to activate the cortex of the brain. Launched in the United States in February 1999, Provigil is indicated for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy. In December 2002, Cephalon filed a supplemental New Drug Application with the FDA seeking to expand its U.S. labeling to cover the treatment of excessive sleepiness in patients with disorders of sleep and wakefulness.

In controlled clinical trials, Provigil has been found to be generally well tolerated, with an incidence of adverse events generally comparable to placebo. The most commonly observed adverse events associated with Provigil were headache, infection, nausea, nervousness, anxiety, and insomnia.

Source: Cephalon Inc.

Posted: May 2003