Advancis completes enrollment in amoxicillin phase 3 trial

By E. Janene Geiss

Philadelphia, June 1 - Advancis Pharmaceutical Corp. said Thursday that it has completed enrollment in its amoxicillin pulsys phase 3 clinical trial for the treatment of pharyngitis/tonsillitis due to Group A streptococcal infections.

Advancis said it concluded enrollment Wednesday with a total of 620 adult and adolescent patients, according to a company news release.

The adult and adolescent pivotal program was designed as a 600-patient, double-blind, double-dummy, non-inferiority phase 3 trial, which began Nov. 9.

Over the coming weeks, patients will complete their treatment and follow-up visits, and Advancis said it will collect and analyze the clinical data.

The company said it expects to publicly report top-line results in mid-August.

If the trial is successful, Advancis said it expects to file a New Drug Application with the Food and Drug Administration for the product early in the first quarter of 2007.

Advancis is comparing its amoxicillin pulsys dosage form for the treatment of pharyngitis/tonsillitis in adults delivered in a once-daily, 775 mg tablet for a period of 10 days to 250 mg of penicillin dosed four times daily, for a total of one gram per day, for 10 days.

The primary endpoint for the study is bacterial eradication, as measured by throat cultures obtained both before and after treatment.

More than 59 million prescriptions for amoxicillin were written in 2005 with total retail sales of about $640 million. Amoxicillin is indicated for a broad range of infections and is commonly prescribed as a first-line therapy for common infections such as middle ear infection, sore throat and sinusitis.

Advancis is a Germantown, Md., pharmaceutical company focused on anti-infective drug products.

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