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Sciele and Addrenex start Phase III trials for ADHD drug

Sciele Pharma and Addrenex Pharmaceuticals have initiated patient enrollment for Phase III clinical trials of Clonicel in the US for the treatment of attention deficit and hyperactivity disorder in children.

In July 2007, Sciele signed an exclusive licensing agreement with Addrenex to market a sustained-release formulation of clonidine hydrochloride for the treatment of attention deficit and hyperactivity disorder (ADHD) and hypertension.

Moise Khayrallah, CEO of Addrenex, said: “We are excited about the benefits Clonicel may provide children between the ages of 6 and 17 who have ADHD. This is the first Phase III clinical trial that is being conducted using a new formulation of clonidine for the treatment of ADHD. Clonicel is a 12-hour, sustained-release formulation, which is designed to reduce the side effects of clonidine.”