Cephalon Inc. has received an approvable letter from the US FDA to market Sparlon (modafinil) tablets [C-IV] for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17. The company submitted a supplemental new drug application (sNDA) to FDA in December 2004.
"Sparlon is distinct from all currently available ADHD therapies. 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 a final approval," said Dr. Paul Blake, executive vice president, Worldwide Medical and Regulatory Operations
Cephalon expects to launch Sparlon, a proprietary dosage form of modafinil, in early 2006 subject to final FDA approval. In August 2005, Cephalon entered into an agreement with McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC Inc. to co-promote Sparlon.
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, states a company release.
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 (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.