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Approvable Letter Issued for Modafinil in Children, Adolescents With Attention-Deficit/Hyperactivity Disorder

FRAZER, Pa., Oct 21, 2005 /PRNewswire-FirstCall via COMTEX News Network/ --Cephalon, Inc. (Nasdaq: CEPH) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) to market SPARLON(TM) (modafinil) Tablets [C-IV] for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents ages six through 17. The company submitted a supplemental new drug application (sNDA) to FDA in December 2004.

"SPARLON is distinct from all currently available ADHD therapies," said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations. "We are excited to offer physicians and families a potential new option in the treatment of ADHD and are working closely with the FDA to obtain final approval."

Cephalon expects to launch SPARLON, a proprietary dosage form of modafinil, in early 2006 subject to final FDA approval. In August 2005, Cephalon announced an agreement with McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc. to co-promote SPARLON.

Cephalon also presented for the first time results of integrated analyses of efficacy and safety data from its three pivotal trials evaluating SPARLON Tablets [C-IV] for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents at a major medical meeting of child and adolescent psychiatrists in Toronto. The three Phase 3 studies in which more than 600 children and adolescents (ages six through 17) with ADHD were randomized to treatment with SPARLON or placebo included two identically designed nine-week, flexible-dosage studies and one seven-week, fixed-dosage study. Patients treated with SPARLON experienced significant improvement compared to placebo as early as the first week, with continued improvement during titration and dose maintenance.

In the clinical trials, SPARLON was generally well tolerated and discontinuation rates due to adverse events were not significantly different from placebo. The most common adverse events associated with SPARLON were generally mild to moderate in nature and included insomnia, headache and decreased appetite. Insomnia and decreased appetite generally occurred upon initiation of treatment and often resolved with continued treatment.

Data from these three trials were submitted to the FDA for evaluation as part of the sNDA.

SPARLON is a new formulation and proprietary dosage strength of modafinil, the active ingredient in PROVIGIL(R) (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. PROVIGIL is not approved to treat ADHD and is available only in 100 mg and 200 mg strengths. If approved, SPARLON is expected to be available in early 2006.

Source: Cephalon, Inc.

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