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Sciele Pharma (SCRX) and Addrenex Pharmaceuticals Announce Analysis of Phase III Clinical Study of Clonicel® for Treatment of ADHD

Sciele Pharma (SCRX), based in Atlanta, Georgia, is a pharmaceutical company founded in 1992. The company specializes in sales, marketing and development of branded prescription products focused on the therapeutic areas of cardiovascular, diabetes, women’s health and pediatrics. Through its focus areas, the company’s products treat health issues such as hypertension, high cholesterol, and Type 2 diabetes.

The company and Addrenex Pharmaceuticals recently 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. Addrenex Pharmaceuticals is a specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Adrenergic dysregulation is implicated in medical conditions such as hypertension, ADHD, migraine and post-menopausal symptoms.

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. Two hundred and twenty-eight children in thirteen centers nationwide between the ages of 6 and 17 diagnosed with ADHD received either placebo or one of two doses of Clonicel for eight weeks. Adverse side effects were mild to moderate in severity with no serious effects reported. Sciele and Addrenex expects to publish the complete clinical results at an upcoming medical conference.

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