Source: Pancreas  |  Posted 6 years ago

By Paula Moyer

WASHINGTON, DC -- December 22, 2005 -- The investigative antibiotic faropenem medoximil (Orapem) is similar to amoxicillin clavulanate (Augmentin) in the treatment of skin and skin-structure infections caused by Staphylococcus aureus and Streptococcus pyogenes, according to a research presented here at the 45[^]th[] Annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

"Beta-lactams are 1 of the oldest classes of antibiotics, penicillins being the first to become available, and the penems are latest," said principal investigator Michael Corrado, MD, president and chief executive officer, Advanced Biologics, a contract research company located in New Hope, Pennsylvania.

Dr. Corrado and colleagues collaborated with researchers at Replidyne, the biopharmaceutical company that is developing Orapem, and conducted a prospective, double-blinded clinical trial to evaluate the effectiveness of faropenem against resistant skin and skin-structure infections. Dr. Corrado delivered his presentation on December 18[^]th[].

In their prospective, double-blinded clinical trial, the investigators compared faropenem 300 mg twice daily against amoxicillin clavulanate at a dose of 625 mg 3 times daily in patients with skin and skin-structure infections. Both drugs were administered for a total of 7 days.

Forty centers throughout Europe, Israel, and South Africa participated in the trial between January 2001 and January 2002. The researchers monitored patients' clinical response 7 to 14 days after completion of the treatment course, which was defined as the test of cure (TOC).

The researchers randomized 298 patients to the faropenem regimen and 295 to amoxicillin clavulanate regimen -- the intention-to-treat and safety populations. Within these groups, 246 patients on faropenem and 227 on amoxicillin clavulanate were evaluable for efficacy, while 154 on faropenem and 139 on amoxicillin clavulanate had data that were microbiologically evaluable.

Among those evaluable for efficacy, 91.1% of those on faropenem and 91.2% of those on amoxicillin clavulanate achieved a clinical cure. Among the intent-to-treat population, 86.6% of those on the study drug and 86.1% of those on the comparator drug achieved this goal. For those with microbiologically evaluable data, the investigators observed eradication in 91.6% and 90.6%, respectively.

Among patients who were evaluable by type of infection, the observers documented cures in 91.4% of 93 patients with S. aureus who were treated with faropenem and 89.7% of 87 amoxicillin clavulanate patients. Among those with S. pyogenes all 35 (100%) of those treated with faropenem and 97.1% of the 35 treated with amoxicillin were cured.

No patients died, and there were 3 adverse events, 1 in the faropenem group and 2 in the amoxicillin clavulanate group, typically consisting of diarrhea and nausea. The rate of adverse events overall was 24.8% in the faropenem group and 33.9% in the amoxicillin clavulanate group. The rate of drug-related adverse events was 11.4% for the faropenem group and 21.0% for the amoxicillin clavulanate group, primarily gastrointestinal.

The safety results were similar whether patients had cellulitis, furunculosis, impetigo, or simple abscess.

The findings showed the faropenem was equivalent to amoxicillin clavulanate for treating uncomplicated infections of the skin and skin structures, Dr. Corrado said. Because of the equivalent efficacy, and the lower rate of drug-related adverse events, the findings support the use of a 7-day course of faropenem at the study dose for treating these infections, he said.

[Presentation title: Prospective, Randomized, Double-Blind, Double-Dummy, Multi-Centre Comparative Trial to Evaluate the Efficacy and Safety of Faropenem Daloxate 300 mg PO BID for 7 Days Vs Co-Amoxiclav (A/C) 625 mg PO TID for 7 Days in the Treatment of Uncomplicated Skin and Skin Structure Infections (uSSSI). Abstract L-1572]