Optimer (OPTR) Updates on DIFICID Treatment on CDAD Patients
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Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) reports 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 Chicago, IL.
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.
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.
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