ADVANCIS COMPLETES TRIAL OF ONCE-DAILY AMOXICILLIN

Advancis Pharmaceutical has announced that its Amoxicillin PULSYS Phase III trial for the treatment of adults and adolescents with pharyngitis/tonsillitis due to Group A streptococcal infections (commonly referred to as strep throat) achieved desired microbiological and clinical endpoints.

Positive trial results were achieved with a once-daily 775-mg dose of Amoxicillin PULSYS for 10 days. The most commonly prescribed treatment for the management of Group A streptococcal pharyngitis is 500-mg of amoxicillin dosed three times daily for 10 days. Amoxicillin is currently not approved for once-daily dosing to treat pharyngitis.

The trial compared the 775-mg once-daily dose for 10 days to 250 mg of penicillin VK dosed four times daily for 10 days in adults and adolescents. Amoxicillin PULSYS demonstrated statistical non-inferiority to the comparator therapy in the trial's primary endpoints -- bacterial eradication at the post-therapy "test-of-cure" visit for patients who fully complied with the trial protocol, as well as in a larger patient population. Amoxicillin PULSYS also demonstrated non-inferiority in the trial's secondary endpoints, including clinical cure at the test-of-cure visit and bacterial eradication at the late post-therapy visit.