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Studies Demonstrate PROVIGIL Improves Symptoms of ADHD in Children

Market Wire, 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(R) (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.

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The Studies

During one 4-week study, 248 children with ADHD (ages six to 13) were randomized to receive either once - or twice-daily doses of modafinil in different combinations of 300 mg doses or placebo. Children weighing more than 30 kg (66 lbs) could be assigned to any of the 300 mg treatment groups or to a group receiving a 400 mg a day dose. In the study, 69 percent of patients were treatment naïve, with 31 percent having had prior stimulant treatment for their symptoms. The primary outcome was a change from baseline in the School Version of the ADHD Rating Scale IV, a tool for the assessment of ADHD symptoms as completed by the patient's teacher.

The 300 mg regimen of PROVIGIL administered once a day and a split dose regimen (200/100) significantly improved symptoms as measured by the teacher-rated ADHD Rating scale (p < 0.05). In addition, the 300 mg once a day dose of PROVIGIL improved symptoms of ADHD across all other rating scales used in the study including the parent rated home version of the ADHD rating scale, and the Conner's Parent ADHD Rating Scale.

Side effects reported in the study were mild to moderate with insomnia, abdominal pain, loss of appetite, cough, fever, and rhinitis reported more frequently in the PROVIGIL treated groups as compared to placebo.

In a second four-week double-blind, placebo-controlled, cross-over study, 48 children (ages six to 13) were randomized to receive placebo or PROVIGIL 100, 200, or 300 mg and children weighing 30 kg (66 lbs) or more could be assigned to any of the 100-300 mg treatment groups or to a group receiving 400 mg once a day. The ADHD Rating Scale-IV (Home version) was the primary efficacy measurement tool. The most significant improvements were seen in patients receiving the 300 or 400 mg dose of PROVIGIL (p < 0.05) as assessed in the home environment by the parent-rated ADHD Rating Scale. The most common side effects observed in the PROVIGIL treated group as compared to placebo were abdominal pain and headache.

Based on results from these studies, Cephalon will be initiating Phase III studies in children with ADHD later this year.

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.

ADHD is a chronic neurobiological disorder that interferes with an individual's capacity to regulate activity level (hyperactivity), inhibit behavior (impulsivity), and attend to tasks (inattention) in developmentally appropriate ways. A diagnosis of ADHD is generally made when these behaviors become excessive, long term and pervasive. ADHD is the most commonly diagnosed disorder in childhood, estimated to affect 3 to 5 percent of school-age children, and occurring three times more often in boys than in girls.

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain.

Cephalon currently employs approximately 1,500 people in the United States and Europe. U.S. sites include the company's headquarters in West Chester, Pennsylvania, and offices and manufacturing facilities in Salt Lake City, Utah. Cephalon's major European offices are located in Guildford, England, Martinsried, Germany, and at Cephalon France in Maisons-Alfort, France.

The company currently markets three proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], GABITRIL(R) (tiagabine hydrochloride) and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II] and more than 20 products internationally. Further information about Cephalon and full prescribing information on its U.S. products is available at www.cephalon.com or by calling 1-800-896-5855.

Studies Demonstrate PROVIGIL Improves Symptoms of ADHD in Children

Market Wire, May, 2003

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