Sciele Pharma begins enrollment in Ph II

USA-based Sciele Pharma, formerly known as the First Horizon Pharmaceutical Corp, says that it has begun enrolling subjects in a pivotal Phase III trial of its drug glycopyrrolate in the treatment of drooling in pediatric patients. The firm explained that the drug is being examined for its safety in moderate-to-severe forms of the condition, which is often associated with cerebral palsy.

Glycopyrrolate is a developmental anticholinergic that received Orphan Drug designation for pediatric drooling from the Food and Drug Administration last year (Marketletter June 26, 2006).

Sciele's executive vice president, Larry Dillaha, said that the firm was pleased with the development of the product, and added that it has the potential to bring meaningful benefit to children suffering from cerebral palsy and a range of neurological conditions.