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

Non-stimulant drug addresses wide range of symptoms of ADHD

DURHAM, N.C., Sept. 10 /PRNewswire/ -- A drug that diminishes the body's hyper-reactivity to stress has been shown to significantly reduce symptoms of attention-deficit hyperactivity disorder (ADHD) in children, according to a phase 3 clinical trial conducted by Addrenex Pharmaceuticals.

The study showed that the new drug, Clonicel, achieved statistically significant improvement over placebo in reducing an aggregate of 18 ADHD symptoms listed by the American Psychiatric Association and used by physicians to diagnose and classify the condition.

"This is the first study to validate the potential for a long-acting version of clonidine -- a widely used hypertension drug -- as a safe and effective treatment for ADHD," said Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals, a small Durham start-up that initiated and coordinated the multicenter trial.

Previous studies of clonidine have indicated that the drug diminishes select symptoms of ADHD, but these studies have been small and inconclusive, Khayrallah said. Moreover, clonidine carries bothersome side effects that have limited its use, including a peak of drowsiness when the drug is absorbed and a subsequent rebound of symptoms when drug levels subside.

Addrenex scientists developed Clonicel to reduce these side effects and treat specific ADHD symptoms that may occur when the body's adrenergic system is in overdrive, producing excessive levels of the stress hormone adrenaline. Such symptoms include emotional outbursts, mood swings, insomnia and hyperreactivity to stress.

"We conducted a well-powered, randomized clinical trial to demonstrate that Clonicel may be effective on its own in treating a multitude of ADHD symptoms, with a favorable side effect profile," said Khayrallah. "We're very excited with the positive data we obtained, and we intend for this study to serve as part of the basis for review
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SOURCE Addrenex
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