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news.Cephalon has received an approvable letter from the FDA to market Sparlon tablets for the treatment of attention-deficit/hyperactivity disorder in children and adolescents ages six through 17.
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The approvable letter represents a delay in the drug’s path to market, as it asks for the company to submit more data before it can be approved. However, Cephalon still hopes to launch the drug in early 2006 subject to final approval.
The company submitted the supplemental new drug application to FDA in December 2004.
“Sparlon is distinct from all currently available ADHD therapies,” said Dr Paul Blake, executive vice president, Worldwide Medical and Regulatory Operations. “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 final approval.”
In three phase III studies in which more than 600 children and adolescents (ages six through 17) with ADHD, patients treated with Sparlon experienced significant improvement compared to placebo as early as the first week, with continued improvement during titration and dose maintenance.