Faropenem medoxomil is a new orally administered
penem antibiotic. Its chiral
tetrahydrofuran substituent at position C2 is responsible for its improved chemical stability and reduced CNS effects, compared with
imipenem.
Faropenem demonstrates broad-spectrum in vitro antimicrobial activity against many Gram-positive and -negative aerobes and anaerobes, and is resistant to hydrolysis by nearly all
beta-lactamases, including extended-spectrum
beta-lactamases and
AmpC beta-lactamases. However,
faropenem is not active against methicillin-resistant Staphylococcus aureus,
vancomycin-resistant Enterococcus faecium, Pseudomonas aeruginosa or Stenotrophomonas maltophilia. Prospective, multicenter, randomized, double-blind, comparative (not vs placebo) clinical trials of acute bacterial
sinusitis (ABS), acute exacerbations of
chronic bronchitis (AECB), community-acquired
pneumonia (CAP) and uncomplicated skin and skin structure
infections (uSSSIs) have demonstrated that
faropenem medoxomil has equivalent efficacy and safety compared with
cefuroxime,
clarithromycin,
azithromycin,
amoxicillin,
cefpodoxime and
amoxicillin-
clavulanate. The evidence supports
faropenem medoxomil as a promising new oral
beta-lactam with proven efficacy and safety for the treatment of a variety of
community-acquired infections. However, the US FDA recently rejected
faropenem for all four indications stating that the clinical trials in ABS and AECB should have been performed versus a placebo. In the CAP studies, the FDA stated that they could not be certain of the validity of the study population actually having the disease and for uSSSI, the FDA stated that only a single trial was not adequate evidence of efficacy for this indication.