Sciele Pharma Completes Phase III Safety Trial For Glycopyrrolate Liquid, A Treatment For Chronic, Moderate-to-Severe Drooling In Pediatric Patients

Main Category: Pediatrics / Children's Health
Also Included In: Clinical Trials / Drug Trials;  Neurology / Neuroscience
Article Date: 10 Jul 2008 - 5:00 PST

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Sciele Pharma, Inc. (NASDAQ:SCRX) announced that it has completed its phase III safety trial utilizing a liquid formulation of glycopyrrolate to treat chronic, moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy as well as from other neurological disorders. This trial was designed to evaluate safety parameters for glycopyrrolate over a six-month period.

"We are excited to have completed this phase III safety trial for glycopyrrolate," said Larry M. Dillaha, M.D., Executive Vice President and Chief Medical Officer of Sciele Pharma. "With the timely completion of this trial, our next step will be to file a New Drug Application (NDA) with the FDA, which we expect to do in the third quarter of 2008. Once approved, this product could provide a meaningful benefit for the care of children who suffer from chronic, moderate-to-severe drooling."

Glycopyrrolate received orphan drug designation from the FDA in June of 2006. The FDA's orphan drug designation is intended to provide incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Following FDA approval, the Orphan Drug Act provides drug market exclusivity for a period of seven years for a product's orphan indication.

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 900 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.

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 the Company believes the expectations expressed in these statements are reasonable, it cannot promise that these expectations will turn out to be correct. Actual results could be materially different from and worse than expectations.

Sciele Pharma, Inc.