my personal edition > paediatrics > news


  E-Mail this DGNews to a colleague

DGNews

Pediatrics Publishes Pivotal Study Showing Sparlon Significantly Improves ADHD Symptoms in Children and Adolescents

FRAZER, PA -- December 5, 2005 -- Cephalon, Inc. today announced that results of a clinical study evaluating Sparlon(TM) (modafinil) Tablets [C-IV] for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents have been published in this month's issue of Pediatrics, the peer-reviewed journal of the American Academy of Pediatrics.

In the study, Sparlon significantly improved the symptoms associated with ADHD as reported by physicians, parents and teachers, and was generally well tolerated.

"In this study, children and adolescents treated with once-daily Sparlon showed improvement in ADHD symptoms, including inattention, impulsivity, and hyperactivity, both at school and at home," said Joseph Biederman, MD, chief, Department of Pediatric Psychopharmacology, Massachusetts General Hospital, professor of Psychiatry at Harvard Medical School, and a lead investigator in the trial. "Sparlon also was associated with a favorable side effect profile."

About the Study
The published study is one of three pivotal studies of Sparlon for the treatment of ADHD in children and adolescents. The 9-week, double-blind, flexible-dose study included 248 children and adolescents with ADHD (ages 6 to 17 years) who were randomized to either once-daily Sparlon or placebo.

The primary endpoint was the teacher/physician-completed ADHD Rating Scale-IV (ADHD-RS-IV) School Version total score. Symptom improvement also was rated using a variety of other scales, including evaluations by parents.

In the study, patients treated with Sparlon showed significantly greater improvement than with placebo in the core symptoms of ADHD at school and home (both P <.0001). By the end of the study, 48 percent of patients treated with Sparlon were rated by physicians as "much" or "very much" improved compared with 17 percent of patients who received placebo (P <.0001).

In the study, 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.

Sparlon
Sparlon is a new dosage form of modafinil, the active ingredient in Provigil(R) (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. Provigil is not approved to treat ADHD. Cephalon has submitted data to the FDA requesting approval to market Sparlon for the treatment of ADHD in children and adolescents. The FDA has not yet determined that Sparlon is safe and effective. If approved, Sparlon is expected to be available in early 2006.


SOURCE: Cephalon, Inc.

E-Mail this DGNews to a colleague

To print, use this version