Advancis says phase 3 study of Amoxicillin Pulsys for strep throat met clinical endpoint

By Lisa Kerner

Charlotte, N.C., Aug. 10 - Advancis Pharmaceutical Corp. said its phase 3 clinical trial of Amoxicillin Pulsys for the treatment of adults and adolescents with pharyngitis/tonsillitis due to group A streptococcal infections (strep throat) met its microbiological and clinical endpoint of bacteriological eradication measured by throat cultures.

The double-blind, double-dummy, randomized, parallel-group trial compared Advancis' Amoxicillin Pulsys 775 milligram tablet dosed once-daily for 10 days to 250 milligrams of penicillin VK dosed four times daily for 10 days in 620 adults and adolescents.

Bacteriological eradication at the post-therapy test-of-cure visit in the per-protocol population was 85% of patients with Amoxicillin Pulsys and 83.4% with penicillin, according to a company news release.

Advancis said it expects full results and safety data from the phase 3 trial by the end of September, followed by the filing of a New Drug Application with the Food and Drug Administration in late 2006 or early 2007.

"If approved for marketing, we believe our once-daily version of amoxicillin would represent a major advance in the most widely used antibiotic in the United States and would be the first and only once-daily amoxicillin therapy approved for marketing in the United States," president and chief executive officer Edward Rudnic said in the release. \

Advancis, based in Germantown, Md., develops and commercializes drug products for the treatment of infectious disease.

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