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Addrenex Pharmaceuticals Announces Positive Phase III Clinical Results for Clonicel to Treat ADHD
Date:9/10/2008

and approval by the FDA, hopefully by next year."

The study showed that Clonicel was statistically superior to placebo on the primary endpoint, the ADHD Rating Scale of 18 symptoms. Clonicel was also statistically superior to placebo on several secondary scales completed by clinicians and parents, including a scale that assesses adrenergic dysregulation. The scale was designed by Joseph Horacek, M.D., a Charlotte neuropsychiatrist and cofounder of Addrenex. Side effects were generally mild to moderate in severity, and no serious adverse events were reported in the study.

A total of 228 children between the ages of 6 and 17 with a diagnosis of ADHD participated in the randomized, double-blind, placebo-controlled trial that compared two doses of Clonicel, 0.2 mg per day and 0.4 mg per day, with placebo. Children received either study medication or placebo for eight weeks at one of 13 study centers nationwide.

If Clonicel is approved by the Food and Drug Administration, the new drug will be marketed by Sciele Pharma under an agreement signed with Addrenex in July 2007.

The introduction of Clonicel into the ADHD market would fill a void that currently exists in the treatment of ADHD, Khayrallah said. While stimulants play an important role in treating ADHD, they do not address all of the symptoms associated with the disorder and may result in unacceptable side effects in some patients.

Because Clonicel targets receptors within the body's stress response center -- the adrenergic system -- it may be more effective in alleviating lesser-known symptoms that accompany ADHD, such as emotional outbursts, mood swings, irritability and hyperreactivity to stress, Horacek said.

"We believe that Clonicel is normalizing the excess of the adrenergic hormones that contribute to many of the symptoms of ADHD," said Horacek.

Stress hormones produce a rapid heart rate, elevated blood pressure, sweating, temperature increases, heightened an
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SOURCE Addrenex
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