Advancis Pharmaceutical has concluded a pre-Phase III meeting with the FDA, which focused on Advancis' adult and adolescent product development program for Amoxicillin PULSYS. Based on the outcome of the meeting, the company believes its planned Phase III clinical trial design and its regulatory strategy for Amoxicillin PULSYS for adults and adolescents with pharyngitis/tonsillitis were acceptable to the FDA. Advancis is now ready to begin the Phase III trial and expects to start enrolling patients later this month.
The primary endpoint for the study will be to demonstrate statistical non- inferiority of bacterial eradication rates between the two treatment arms, as measured by throat cultures both before and after therapy. The trial is designed to utilize approximately 50 sites across the U.S. and Canada and is anticipated to last from six to nine months.