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Analysis Of Data From Two Phase 3 Studies Shows DIFICID® Offered Faster Diarrheal Symptom Improvement Than Oral Vancomycin In Patients With Cancer Being Treated For Clostridium Difficile-Associated Diarrhea (CDAD)
May 16, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced the results of a retrospective subpopulation analysis of 183 patients with cancer from the company's two large Phase 3 trials, which showed the cancer patients with
Clostridium difficile-associated diarrhea (CDAD) who were treated with DIFICID® (fidaxomicin) tablets experienced resolution of their diarrheal symptoms approximately two days faster than those treated with oral vancomycin. These results will be presented on
June 2nd at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in
"CDAD is a serious complication for cancer patients and potentially can disrupt the effects of cancer treatment and result in dehydration, impaired functioning, fatigue and, in severe cases, death," said
Kathleen Mullane, D.O., Associate Professor of Medicine, Section of Infectious Diseases and Global Health, at the
University of Chicago. "The results of this analysis indicate DIFICID may provide faster resolution of diarrhea when compared to vancomycin in a subset of cancer patients. While further studies are needed to confirm these findings, the results suggest the drug may serve as an important treatment option for this population and others at heightened risk for CDAD."
The analysis assessed treatment outcomes between patients with active cancer and patients without cancer who were treated with either DIFICID or oral vancomycin in two large, pivotal, Phase 3 studies. Results showed that overall, cancer patients with CDAD had slower time to resolution of diarrhea (TTROD) than non-cancer patients (100 hours vs. 55 hours, respectively; K-M log rank p<0.001). However, when treatment outcomes were compared between cancer patients receiving DIFICID or oral vancomcyin, patients treated with DIFICID experienced resolution of diarrhea two days faster than those treated with vancomycin (74 hours vs. 123 hours, respectively; K-M log rank p=0.045). The overall safety profile was similar between the DIFICID and vancomycin treatment groups.