Sciele Completes Pivotal Phase III Program for Glycopyrrolate in Pediatric Patients with Chronic, Moderate-to-Severe Drooling
ATLANTA--(BUSINESS WIRE)--Sept. 16, 2008 - Sciele Pharma, Inc. (NASDAQ: SCRX) today announced the completion of a pivotal Phase III program to support an NDA filing for glycopyrrolate liquid. Glycopyrrolate is being studied for use by pediatric patients with chronic, moderate-to-severe drooling as a result of cerebral palsy, mental retardation, or any other neurological condition associated with drooling.
The Company completed its open-label, 24-week, multi-center study to assess the safety of oral glycopyrrolate liquid for the treatment of chronic, moderate-to-severe drooling in pediatric patients three to 18 years of age. Administration of the glycopyrrolate liquid was found to be well-tolerated in pediatric patients. No unexpected safety issues were identified in patients using glycopyrrolate in the pivotal phase III safety trial.
Sciele also conducted a multi-center randomized, double-blind, placebo-controlled eight-week efficacy and safety study in children ages three through 18 years with cerebral palsy, mental retardation, or any other neurological condition associated with drooling. This study showed that liquid glycopyrrolate, investigated for use in treating chronic, moderate-to-severe drooling, reached its primary endpoint. The primary endpoint was the responder rate, which was based on change in the modified Teacher's Drooling Scale (mTDS) as administered by parents/caregivers from baseline to week eight. Results of this study showed that patients treated with glycopyrrolate had a significantly higher rate of response than patients treated with placebo.
Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, "We are pleased to complete this pivotal Phase III program, which will supplement our NDA filing planned for the fourth quarter of 2008. Upon FDA approval, this product may 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, which 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 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.
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.
Joseph T. Schepers, 678-341-1401
Director of Investor Relations
Posted: September 2008