Sparlon (modafinil) tablets [C-IV] is a new formulation and proprietary dosage strength of modafinil, the active ingredient in Provigil, 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 FDA’s Psychopharmacologic Drugs Advisory Committee voted not to recommend FDA approval of Sparlon, Cephalon’s investigational medication for the treatment of 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.
This news comes as the FDA is debating whether or not to strengthen the warnings placed upon the labels of approved ADHD drugs.
The advisory panel’s recommendation will be considered by the FDA in its review of the supplemental new drug application (sNDA) that Cephalon submitted for Sparlon in December 2004.
Cephalon’s executive vice president of worldwide medical and regulatory operations, Dr Paul Blake, expressed his disappointment at the committee’s recommendation, and said the company will continue talks with the FDA to determine what the next steps to be taken.
The company also revealed that, in light of the advisory committee’s recommendation, it is reducing its 2006 sales guidance by $100 million to $1.45-$1.50 billion. Consistent with this reduction, guidance for CNS franchise sales also is reduced by $100 million to $665-$715 million.