ADVANCIS BEGINS AMOXICILLIN PULSYS PHASE III TRIAL

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Advancis Pharmaceutical has begun enrollment in its Phase III clinical trial for Amoxicillin PULSYS for adults and adolescents with pharyngitis/tonsillitis.

The Phase III trial to support product approval for Amoxicillin PULSYS for the treatment of acute pharyngitis/tonsillitis in adults and adolescents due to Group A streptococcal infections is designed as a two-arm, double-blind, double-dummy, non-inferiority trial for its pulsatile form of amoxicillin. 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 1 gram per day, for 10 days.

The primary endpoint for the study will be to demonstrate statistical noninferiority of bacterial eradication rates between the two treatment arms, as measured by throat cultures both before and after therapy.