The Lancet Infectious Diseases Publishes Phase 3 Study Results Confirming Superior Rate Of Sustained Clinical Response Of DIFICID® (fidaxomicin) Tablets Compared To Oral Vancomycin In Adult Patients With Clostridium Difficile Infection (CDI)
SAN DIEGO, March 26, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today The Lancet Infectious Diseases has published results from the European and North American Phase 3 trial evaluating the safety and efficacy of DIFICID® (fidaxomicin) tablets in the treatment of adult patients with Clostridium difficile infection (CDI). The Phase 3 non-inferiority trial showed that DIFICID had similar clinical cure rates as oral vancomycin in the initial treatment of the disease. In addition, secondary endpoint analyses showed that DIFICID provided superior rates of sustained clinical response through 25 days after the end of treatment and had significantly lower recurrence rates within four weeks of treatment. The article, titled "Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial," was published online ahead of print in The Lancet Infectious Diseases.
"Resolution of symptoms without recurrence is vital in the long-term management of C. difficile. We are encouraged by the results of this study that support the superiority of DIFICID in producing sustained clinical response and lowering rates of recurrence at 25 days after treatment compared with oral vancomycin," said Sherwood L. Gorbach, M.D., co-author and Optimer's Chief Scientific Officer and Senior Vice President. "To the extent treatments for CDAD can help sustain a clinical response and reduce recurrences, they would be able to offer an improvement in treatment options for patients. We look forward to conducting further research to understand how DIFICID may particularly benefit patients with continued unmet medical needs."
The results of the study showed that 87.7% of DIFICID-treated patients achieved the primary endpoint of clinical cure, defined as resolution of diarrhea and no further need for treatment, compared to an 86.8% cure rate in vancomycin-treated patients. Among patients who achieved initial clinical cure following treatment with oral vancomycin, 26.9% had a recurrence of disease within four weeks, compared with only 12.7% of patients who achieved a clinical cure with DIFICID (p =0.0002). This difference in recurrence was reflected in a statistically superior rate of sustained clinical response through 25 days after the end of treatment for the DIFICID treatment group versus vancomycin-treated patients (p=0.001).
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $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
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV