Advancis Pharmaceutical (AVNC) Concludes Pre-Phase III Meeting with FDA for Development of Keflex PULSYS Product Candidate

June 26, 2007 1:41 PM EDT

Advancis Pharmaceutical Corporation (Nasdaq: AVNC) has concluded a Pre-Phase III meeting with the U.S. Food and Drug Administration (FDA), which focused on Advancis\' product development program for its once-daily Keflex PULSYS product candidate. Based on the outcome of the meeting, the Company believes its planned non-inferiority Phase III clinical trial design and its regulatory strategy for Keflex PULSYS for adults and adolescents with uncomplicated skin infections were acceptable to the FDA.

On June 25, 2007, Advancis completed a meeting with the FDA\'s Division of Anti-Infective and Ophthalmology Products to discuss the Company\'s Phase III trial and regulatory strategy to support product approval for Keflex PULSYS for the treatment of uncomplicated skin and skin structure infections (uSSSIs) in adults and adolescents due to susceptible Staphylococcus aureus and/or Streptococcus pyogenes. Advancis\' planned Phase III trial is designed as a two-arm, double-blind, non-inferiority trial with a minimum enrollment of 600 patients.

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