Analysis Of Data From Two Phase 3 Studies Shows DIFICIDÂ® Offered Faster Diarrheal Symptom Improvement Than Oral Vancomycin In Patients With Cancer Being Treated For Clostridium Difficile-Associated Diarrhea (CDAD)
SAN DIEGO, 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 Chicago, IL.
"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.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV