Cephalon gets FDA approval letter for Sparlon to treat ADHD

By E. Janene Geiss

Philadelphia, Oct.21 - Cephalon Inc. announced Friday that it received an approval letter from the Federal Drug Administration to market Sparlon tablets for use in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).

In a company news release, officials said it expects to launch Sparlon, a proprietary dosage form of modafinil in early 2006, subject to final FDA approval.

In August, Cephalon announced an agreement with McNeil Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc. to co-promote Sparlon, officials said.

"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 clinical trials, the drug or a placebo was tested on more than 600 children and adolescents, ages 6 through 17, with ADHD. Patients treated with Sparlon experienced significant improvement compared to the placebo as early as the first week with continued improvement throughout the trial, officials said.

Sparlon was generally well tolerated and discontinuation rates due to adverse events were not significantly different from the placebo, officials said.

The Frazer, Pa.-based biopharmaceutical company submitted a supplemental new drug application for Sparlon in December 2004.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.