Cephalon says FDA advisory committee recommends against approval of Sparlon ADHD drug

By Angela McDaniels

Seattle, March 23 - Cephalon Inc. said the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee voted not to recommend approval of Sparlon (modafinil) tablets, the company's investigational medication for the treatment of attention deficit-hyperactivity disorder 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, according to a company news release.

Cephalon received an approvable letter from the FDA for Sparlon in October.

"We will continue our discussions with the FDA to determine the next steps in the review of this drug application," Paul Blake, executive vice president of Worldwide Medical and Regulatory Operations, said in the release.

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, but the FDA is not bound by the committee's recommendation.

The company left its previously issued 2006 basic adjusted income guidance of $3.80 to $4.00 per common share unchanged. Cephalon reduced, however, its 2006 sales guidance by $100 million to between $1.45 billion and $1.50 billion and its 2006 central nervous system franchise sales guidance by $100 million to between $665 million and $715 million.

Sparlon is a new formulation and proprietary dosage strength of modafinil, the active ingredient in Provigil (modafinil) tablets, 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, the company said.

Cephalon is a biopharmaceutical company based in Frazer, Pa.

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