Advancis expects to enroll a total of at least 600 patients throughout the 2005/2006 respiratory infection season. The company anticipates completing enrollment by June 2006 and announcing the trial results in the third quarter of 2006.
In the trial Advancis will compare its Amoxicillin Pulsys dosage form for the treatment of pharyngitis delivered in a once-daily 775 mg tablet for 10 days to the standard comparator therapy of 250 mg of penicillin VK dosed four times daily, for a total of one gram per day, for 10 days.
The company believes the study will be the largest pharyngitis and tonsillitis trial evaluating the safety and efficacy of an aminopenicillin class antibiotic ever conducted.
“We believe this pivotal trial will provide a definitive assessment of the efficacy of Amoxicillin Pulsys as well as the value of our pulsatile dosing technology,” said Dr Edward Rudnic, Advancis chairman and CEO.