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NEW DRUG DEVELOPMENTS

Faropenem Medoxomil

Assistant Professor of Pharmacy Practice, Midwestern University Chicago College of Pharmacy, Downers Grove, IL

Christopher W Crank, PharmD BCPS AQ

Infectious Disease, Clinical Specialist, Infectious Diseases, Department of Pharmacy, Rush University Medical Center, Chicago, IL

Alexander H Philbrick, PharmD

Pharmacy Manager, Dominicks Pharmacy, Chicago, IL

Reprints: Dr. Gettig, Midwestern University Chicago College of Pharmacy, 555 31st St., Downers Grove, IL 60515, fax 630/515-6958, jgetti{at}midwestern.edu

OBJECTIVE: To review the literature concerning the in vitro activity, pharmacokinetic properties, in vivo efficacy, and adverse events associated with a new penem antibiotic, faropenem medoxomil.

DATA SOURCES: We conducted a search of MEDLINE/PubMed and International Pharmaceutical Abstracts databases for articles or abstracts using the terms faropenem, faropenem daloxate, faropenem medoxomil, SUN5555, SY5555, WY49605, RU67655, ALP201, BLA 857, and YM 044 and published through July 2007. Information on poster presentations was obtained from the drug's manufacturer. Additional articles were identified from citations in the bibliographies of review articles. Articles written in languages other than English were excluded.

STUDY SELECTION AND DATA EXTRACTION: All published reports that evaluated faropenem (or its chemical synonyms) and faropenem medoxomil were used in this review. Abstracts subsequently published as full reports were excluded, and only the resulting reports were included. Abstracts without subsequently published reports were included.

DATA SYNTHESIS: The in vitro activity of faropenem has been evaluated extensively against respiratory pathogens and less extensively against aerobic gram-positive, gram-negative, and anaerobic organisms. Prospective, randomized, multicenter clinical trials have demonstrated noninferiority of faropenem to comparators for the treatment of acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis, and uncomplicated skin and skin structure infections. Adverse events associated with faropenem appear to be minimal and include nausea, vomiting, and diarrhea.

CONCLUSIONS: Faropenem has demonstrated excellent in vitro activity against common respiratory pathogens, many aerobic gram-positive organisms, and anaerobes. Activity against gram-negative organisms is more reserved. In vivo data suggest that faropenem is efficacious in treating community-acquired infections including uncomplicated skin and skin structure infections; however, more data may help to characterize faropenem's place in antimicrobial therapy. Replidyne, Inc., the manufacturer of faropenem, is conducting studies to address the Food and Drug Administration's concerns that resulted in a nonapprovable letter in October 2006.

Key Words: faropenem, faropenem daloxate, faropenem medoxomil, pharmacodynamics, pharmacokinetics, resistance

Published Online, December 19, 2007. www.theannals.com, DOI 10.1345/aph.1G232