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FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents
FRAZER, P.A. -- March 24, 2006 -- Cephalon, Inc. announced that the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend FDA approval of Sparlon(TM) (modafinil) Tablets [C-IV], the company's investigational medication for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents.
The committee voted unanimously that Sparlon is effective for its intended use but recommended that the company collect additional data to support the safety of the drug in children and adolescents with ADHD.
"We are obviously disappointed with the recommendation of the advisory committee. We will continue our discussions with the FDA to determine the next steps in the review of this drug application," said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations.
The advisory committee's recommendation will be considered by the FDA in its review of the Supplemental New Drug Application that Cephalon submitted for Sparlon, a proprietary dosage form of modafinil, in December 2004. The FDA is not bound by the committee's recommendation, but takes its advice into consideration when reviewing investigational drugs seeking approval. Cephalon received an approvable letter from the FDA with respect to Sparlon in October 2005.
About Sparlon
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.
Sparlon is chemically distinct from currently approved therapies and if approved, would provide a unique option for ADHD treatment. PROVIGIL is not approved to treat ADHD and is available only in 100 mg and 200 mg strengths. Sparlon should not be used in combination with PROVIGIL(R) or any other medications that contain modafinil.
SOURCE: Cephalon, Inc.
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