Advancis Pharmaceutical to begin Amoxicillin Pulsys phase III trial

By Jennifer Chiou

New York, Nov. 3 - Advancis Pharmaceutical Corp. said it concluded a positive pre-phase III meeting for Amoxicillin Pulsys with the Food and Drug Administration and expects to begin a phase III trial. with completion expected in the third quarter of 2006.

The company said it believes its planned phase III clinical trial design and regulatory strategy for Amoxicillin Pulsys, which is for adults and adolescents with pharyngitis/tonsillitis, were acceptable to the FDA.

Advancis added it expects to start enrolling at least 600 patients this month.

"Based on our FDA meeting yesterday [Wednesday], we believe the analysis of our already-completed studies, relevant literature data and the results of our upcoming phase III trial, if successful, will be sufficient to support a NDA [new drug application] filing for Amoxicillin Pulsys for adults and adolescents with strep throat in late 2006," chairman and chief executive officer Edward Rudnic said in a news release.

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

Based in Germantown, Md., Advancis is a pharmaceutical company that develops anti-infective products with its once-a-day pulsatile delivery technology, Pulsystm.

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