Sciele Pharma And Addrenex Pharmaceuticals Announce Positive Phase III Clinical Results Of Clonicel For ADHD

Main Category: ADHD
Also Included In: Psychology / Psychiatry
Article Date: 12 Sep 2008 - 4:00 PDT

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Sciele Pharma, Inc. (NASDAQ:SCRX) and Addrenex Pharmaceuticals 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.

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. The study enrolled 228 children between the ages of 6 and 17 who had a diagnosis of ADHD. Children received either placebo or one of two doses of Clonicel, 0.2 mg/day or 0.4 mg/day, for eight weeks. Adverse events were mild to moderate in severity and no serious adverse events were reported in the study. Thirteen centers nationwide participated in the study. Sciele and Addrenex expect to publish the complete clinical results at an upcoming medical conference.

Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, "We are pleased to announce the positive results for the Phase III trial investigating the use of Clonicel to treat ADHD. Addrenex is also continuing to enroll patients in an additional Phase III trial using Clonicel in combination with stimulants such as methylphenidate and dextro-amphetamine / amphetamine to treat ADHD."

Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals, said, "This is the first Phase III clinical study using Clonicel, an extended-release formulation of clonidine. Clonidine is already approved for hypertension. Clonicel is designed to normalize excess adrenergic hormones that may cause many symptoms of ADHD."

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs more than 1,000 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork. http://www.sciele.com

About Addrenex

Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Addrenex Pharmaceuticals is based in Durham, North Carolina, on the edge of Research Triangle Park. The company was formed in 2006 by a practicing physician and a drug development expert with the mission to explore the impact that neurotransmitter regulation has on a variety of diseases and disorders. Addrenex identified adrenergic regulation as its initial research focus. Adrenergic dysregulation is implicated in medical conditions such as hypertension, ADHD, migraine, and post-menopausal symptoms. Addrenex will use the knowledge and experience gained from developing CLONICEL® as the foundation for additional discovery and development in the area of adrenergic regulation.

Safe Harbor Statement

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations.

Sciele Pharma, Inc.