Chart: Fighting C. Difficile: Beyond Optimer's Fidaxomicin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Optimer released positive data Feb. 4 from its second pivotal Phase III trial of fidaxomicin, raising hopes that hospitals will soon have a new weapon for fighting new deadly strains of Clostridium difficile, a bacterium that occurs naturally in the gut and is ordinarily benign. Problems arise, however, when antibiotics used to treat hospital-acquired infections eliminate other resident flora, allowing novel and toxic strains of C. diff to proliferate. Outbreaks of the disease, typified by diarrhea, nausea and in severe cases, colitis, sepsis and death, have made headlines in the United Kingdom and Canada.