Optimer Pharmaceuticals, Inc. (OPTR) Release: DIFICID(TM) Demonstrated Early Superiority in the First 12 Days Compared to Vancomycin in New Analysis of Phase 3 Study Results
10/20/2011 10:53:08 AM
SAN DIEGO, Oct. 20, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced today that data being presented at the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) demonstrate that patients treated with DIFICID (fidaxomicin) tablets for Clostridium difficile-associated diarrhea (CDAD) experienced faster resolution of diarrhea and lower risk of death during the first 12 days following initiation of treatment compared to patients treated with vancomycin. The retrospective analysis of results from two large, multi-national Phase 3 clinical studies, which assessed the efficacy of DIFICID versus vancomycin for the treatment of CDAD in adults, was completed by researchers from the National Institute for Health Research (NIHR) Biomedical Research Centre, Oxford, a research partnership between the Oxford Radcliffe Hospitals and the University of Oxford.
In the analysis, patients treated with DIFICID experienced a 37% reduction in persistent diarrhea or death through day 12 of the study (95% CI: 2-60%; p=0.037) compared to those treated with vancomycin. These data are among those featured in a late-breaking poster presentation at the IDSA annual meeting being held in Boston from October 20-23.
"We were encouraged by the results of the Phase 3 clinical studies and believed that a more comprehensive look at the patient characteristics of the Phase 3 study participants might yield even greater insights into the use of DIFICID for the treatment of CDAD," said Sarah Walker, PhD, Senior Statistician at the NIHR Biomedical Research Centre, Oxford, and the primary author of the analysis. "In our analysis, we found that DIFICID not only reduced persistent diarrhea and early deaths in patients within the first 12 days following initiation of treatment but also significantly reduced persistent diarrhea, disease recurrence or death through day 40 of the study."
The analysis was independently funded by the NIHR Biomedical Research Centre, Oxford, a research partnership between the Oxford Radcliffe Hospitals and the University of Oxford.