Fidaxomicin: first-in-class macrocyclic antibiotic

Abstract

The incidence of Clostridium difficile has doubled over the past 15 years, and rising mortality rates associated with this infection have followed in its wake. C. difficile infection (CDI) has supplanted methicillin-resistant Staphylococcus aureus as the major cause of nosocomial infection. An insufficient response rate to currently available CDI therapies has prompted the search for new and alternative treatment modalities for this disease. The investigational pipeline includes evaluation of new antimicrobial agents that exhibit good activity against C. difficile without altering normal gut flora, C. difficile toxin-absorbing compounds, and preformed antibodies and vaccines against C. difficile toxin. In two robust clinical trials comparing fidaxomicin to vancomycin in the treatment of CDI, treatment with fidaxomicin demonstrated a superior global cure (cure without recurrence) rate compared with the current gold standard, vancomycin. Fidaxomicin, the first of a new class of macrocyclic antimicrobial agents, represents an advance in the management of CDI.

Keywords::

• Clostridium difficile
• difimicin
• fidaxomicin
• macrocyclic antibiotic
• OPT-80
• PAR-101

Financial & competing interests disclosure

The authors have disclosed the following financial and competing interests: Kathleen M Mullane: Clinical Trials Investigator and Publications Committee, Optimer Pharmaceuticals, Inc.; consultancy for Publication Committee; Sherwood Gorbach: Chief Scientific Officer, Optimer Pharmaceuticals, Inc.; salary and stock options. Cempra Pharmaceuticals, Inc., Scientific Advisor. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.