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Advancis Pulsys platform gets second try

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advancis is moving ahead with another Phase III trial of its Pulsys pulsatile formulation of amoxicillin, the firm says Nov. 3. After a pre-Phase III meeting with FDA to discuss the 600-patient trial, the firm says it is on track to submit a 505(b)(2) NDA for treatment of adults and adolescents with strep throat in "late 2006." The two-arm trial will compare a 10-day regimen of once-daily amoxicillin Pulsys to penicillin VK dosed four times daily. Advancis previously indicated that the new trial could be its last chance to prove the viability of the Pulsys technology. The amoxicillin formulation previously failed to show statistical non-inferiority to penicillin in two Phase III studies (1Pharmaceutical Approvals Monthly October 2005, p. 8)...
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