Sciele and Addrenex say ADHD drug reaches goals

Sciele Pharma Inc. and partner Addrenex Pharmaceuticals said Wednesday their drug candidate Clonicel decreased symptoms of Attention Deficit Hyperactivity Disorder compared to a placebo.

The eight-week, late stage trial compared two doses of Clonicel, or extended-release clonidine, to a placebo. The study met its primary goal of a statistically significant reduction in symptoms, which were measured on a rating scale developed by the American Psychiatric Association.

In the trial, 228 patients between the ages of 6 and 17 were given either a 0.2 mg or 0.4 mg dose of Clonicel, or a placebo. The drug has already received regulatory approval as a treatment for hypertension, and Sciele and Addrenex said the extended-release version is designed to reduce excesses of hormones, which can cause many ADHD symptoms.

The companies say they are enrolling patients in other late-stage trials of Clonicel.