Advancis begins Amoxicillin Pulsys phase 3 trial for pharyngitis, tonsillitis

By Angela McDaniels

Seattle, Nov. 11 - Advancis Pharmaceutical Corp. said it has begun enrolling patients in its phase 3 clinical trial of Amoxicillin Pulsys for the treatment of pharyngitis/tonsillitis.

Advancis plans to enroll at least 600 patients throughout the 2005/2006 respiratory infection season in 50 sites across the United States and Canada.

The endpoint of the trial is to compare the efficacy of Amoxicillin Pulsys and penicillin VK in eradicating bacteria, the company said.

Patients will receive Amoxicillin Pulsys delivered in a once-daily, 775 milligram tablet for 10 days or the standard comparator therapy of 250 milligrams of penicillin VK, four times daily, for 10 days.

The company expects to announce the trial results in the third quarter of 2006. If the trial is successful, Advancis said it will file a new drug application with the U.S. Food and Drug Administration for the product in late 2006.

If approved, Amoxicillin Pulsys would be the first once-daily product in the aminopenicillin class for the treatment of pharyngitis and use only one-half the amount of amoxicillin used in current products, the company said.

Advancis is a pharmaceutical company based in Germantown, Md., that develops pulsatile drug products for the treatment of infectious disease.

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