Sparlon is a new formulation and proprietary dosage strength of modafinil developed by Cephalon, the active ingredient in Provigil 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. Provigil is not yet approved to treat ADHD and is available only in 100 mg and 200 mg strengths. If it is approved, Sparlon is expected to be available in early 2006

Sparlon is distinct from all the currently available ADHD therapies. It ha offered the physicians and families a potential new option in the treatment of ADHD and is working closely with the FDA to obtain final approval.

Cephalon has launched Sparlon, a proprietary dosage form of modafinil, in the early part 2006 subject to final FDA approval. In August 2005, Cephalon announced an agreement with McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc. to encourage Sparlon.

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

The three Phase 3 studies in which more than 600 children and adolescents with ADHD were randomized to treatment with Sparlon or placebo included two identically designed nine-week, flexible-dosage studies and a one seven-week, fixed-dosage study. Patients treated with Sparlon experienced a significant improvement compared to placebo as early as the first week