Sciele Pharma, Inc. (NASDAQ:SCRX) and Addrenex Pharmaceuticals today
announced that the preliminary analysis of the Phase III clinical study
investigating the use of Clonicel® for the
treatment of Attention Deficit Hyperactivity Disorder (ADHD) showed
statistically significant improvement over placebo.
The study indicated that Clonicel achieved statistical significance on
the primary endpoint, which is based on the ADHD Rating Scale of 18
symptoms developed by the American Psychiatric Association and used by
physicians to classify and diagnose ADHD.
The study was a Phase III, randomized, double-blind, placebo-controlled
clinical trial comparing two doses of Clonicel to placebo. The study
enrolled 228 children between the ages of 6 and 17 who had a diagnosis
of ADHD. Children received either placebo or one of two doses of
Clonicel, 0.2 mg/day or 0.4 mg/day, for eight weeks. Adverse events were
mild to moderate in severity and no serious adverse events were reported
in the study. Thirteen centers nationwide participated in the study.
Sciele and Addrenex expect to publish the complete clinical results at
an upcoming medical conference.
Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, “We
are pleased to announce the positive results for the Phase III trial
investigating the use of Clonicel to treat ADHD. Addrenex is also
continuing to enroll patients in an additional Phase III trial using
Clonicel in combination with stimulants such as methylphenidate and
dextro-amphetamine / amphetamine to treat ADHD.”
Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals, said, “This
is the first Phase III clinical study using Clonicel, an
extended-release formulation of clonidine. Clonidine is already approved
for hypertension. Clonicel is designed to normalize excess adrenergic
hormones that may cause many symptoms of ADHD.”
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales,
marketing and development of branded prescription products focused on
the therapeutic areas of Cardiovascular, Diabetes, Women's Health and
Pediatrics. The Company's Cardiovascular and Diabetes products treat
patients with high cholesterol, hypertension, high triglycerides,
unstable angina and Type 2 diabetes; its Women's Health products are
designed to improve the health and well-being of women and mothers and
their babies; and its Pediatrics products treat allergies, asthma,
coughs and colds, and attention deficit and hyperactivity disorder
(ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele
employs more than 1,000 people.
