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 has 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 as administered by parents or 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, 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.”