Sciele Pharma Begins Pivotal Trial of Chronic Drooling Treatment

Sciele Pharma announced that it has begun enrolling patients in a pivotal Phase III safety trial utilizing glycopyrrolate to treat chronic, moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy, as well as other neurological disorders. This trial has been designed to evaluate safety parameters for the six-month period during which patients are expected to be on active treatment.

The company expects to file a new drug application (NDA) for glycopyrrolat in mid-2008 and to launch the product in mid-2009 after FDA approval.

"We are pleased with our progress in developing this product, which may provide a meaningful benefit for the care of children suffering from cerebral palsy and other neurological diseases," Larry Dillaha, executive vice president and chief medical officer, said. "This new formulation was developed from our internal product pipeline and is the result of our increased focus on product development and the expanded expertise of our clinical group."

Glycopyrrolate received orphan drug designation from the FDA in June 2006. 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 marketing exclusivity for a period of seven years for a product's orphan indication, according to the company. Additional incentives include exemption from FDA user fees and FDA assistance in clinical trial design.