Advancis Completes Enrollment in Pediatric Amoxicillin PULSYS Trial

Advancis Pharmaceutical has completed enrollment ahead of schedule in the company's pediatric Amoxicillin PULSYS Phase III clinical trial for the treatment of pharyngitis/tonsillitis due to Group A streptococcal infections.

Advancis' pediatric pivotal program is designed as a 500-patient, investigator-blind, noninferiority Phase III trial for a "sprinkle" formulation of Amoxicillin PULSYS for the treatment of pediatric patients with acute pharyngitis/tonsillitis.

The company now has enrolled 571 pediatric patients and expects to have final enrollment near 600 patients. Over the coming weeks, pediatric patients will complete their treatment and follow-up visits, and Advancis and its clinical research organization will collect and analyze the clinical data.

Trial enrollment began Jan. 5, and the company expects to publicly report top-line results for the trial in July. Advancis enrolled additional pediatric patients beyond the 500-patient target to help ensure a sufficient number of evaluable patients (patients who complied with the protocol requirements) as rapid trial enrollment rendered periodic monitoring of evaluability rates less meaningful.