
Press Release from Cephalon, December 5, 2005
Study Shows 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.
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