Company Overview
  Fidaxomicin (OPT-80)
  Pruvel™ (prulifloxacin)
  Clostridium difficile infection (CDI)


  • Fidaxomicin (OPT-80)
    Fact Sheet
    PDF


  • Fidaxomicin PAE against C. difficile
    Fidaxomicin and Vancomycin Postantibiotic Effect against C. difficile,presented at the 10th Biennial Congress of the Anaerobe Society of the Americas, July 2010
    Poster PDF


  • Fidaxomicin PAE against C difficile
    Fidaxomicin and Vancomycin Postantibiotic Effect against C. difficile, presented at the 10th Biennial Congress of the Anaerobe Society of the Americas, July 2010
    Abstract PDF


  • Fidaxomicin in vitro Activity
    In vitro Activity of Fidaxomicin (OPT-80) and Comparator Antimicrobial Agents and REA Typing of Clostridium difficile Recovered During a North American Clinical Trial, presented at the 10th Biennial Congress of the Anaerobe Society of the Americas, July 2010
    Abstract PDF


  • Fidaxomicin 2nd Phase 3 Additional Data on Concomitant Antibiotics
    Randomized Clinical Trial (RCT) in Clostridium difficile Infection (CDI) Confirms Superiority of Fidaxomicin over Vancomycin, an oral presentation at DDW, May 2010
    Abstract PDF


  • Fidaxomicin 2nd Phase 3 Top-line Data plus BI strain type subgroups
    Randomized Clinical Trial in Clostridium difficile infection Confirms Equivalent Cure Rate and Lower Recurrence Rate of Fidaxomicin versus Vancomycin, poster presented at 20th ECCMID, April 2010
    Poster PDF


  • Fidaxomicin North American Phase 3 data used to assess ESCMID Severity Criteria
    Three Simple ESMID Severity Criteria Predict Poor Cure Rate and Slower Resolution of Diarrhea in Clostridium difficile infection (CDI), poster presented at 20th ECCMID, April 2010
    Poster PDF


  • Fidaxomicin (OPT-80) North American Phase 3 Additional Data on TTROD
    Faster Time to Resolution of Diarrhea with Fidaxomicin vs. Vancomycin in Patients with Clostridium difficile Infection (CDI), poster presented at the 47th IDSA annual meeting, October 2009
    Poster PDF


  • Fidaxomicin (OPT-80) FDX vs. Vancomycin with CA's
    Effect of Concomitant Antibiotics on Treatment of Clostridium difficile (CDI) Infection with Fidaxomicin or Vancomycin, poster presented at the 47th IDSA annual meeting, October 2009
    Poster PDF


  • Fidaxomicin (OPT-80) CDI Risk Factors: Age, Albumin, and Fever
    Age, Serum Albumin, and Leukocytosis/Fever Predict Clinical Outcomes, poster presented at the 47th IDSA annual meeting, October 2009
    Poster PDF


  • Fidaxomicin (OPT-80) North American Phase 3 Additional data on Recurrence
    Low Recurrence Rate among Patients with C. difficile Infection (CDI) Treated with Fidaxomicin (FDX), poster presented at the 49th ICAAC, September 2009
    Poster PDF


  • Fidaxomicin (OPT-80) Phase 3 Additional Data on Susceptibilities
    Comparative Fidaxomicin Susceptibilities of Isolates Collected at Baseline, Failure, and Recurrence from Patients in a Phase III Trial of Clostridium difficile Infection (CDI), poster presented at the 49th ICAAC, September 2009
    Poster PDF


  • Fidaxomicin (OPT-80) North American Phase 3 Additional data on PK/PD
    Pharmacokinetics/Pharmacodynamics (PK/PD) of Fidaxomicin in Treatment of Clostridium difficile Infection (CDI), poster presented at the 49th ICAAC, September 2009
    Poster PDF


  • Fidaxomicin (OPT-80) Phase 3 Additional data on Strain Typing
    Restriction Endonuclease Analysis (REA) Typing of Clostridium difficile in a Phase 3 Treatment Trial of Fidaxomicin vs Vancomycin: Decreased Cure Rate for Epidemic BI/NAP1/027 Strain, poster presented at the 49th ICAAC, September 2009
    Poster PDF


  • Fidaxomicin (OPT-80) North American Phase 3 Additional Data on Safety
    Safety of Fidaxomicin Versus Vancomycin in Treatment of Clostridium difficile Infection, poster presented at the 49th ICAAC, September 2009
    Poster PDF


  • Fidaxomicin (OPT-80) North American Phase 3 Top-line Data
    OPT-80 versus vancomycin in Clostridium difficile infection: Results of a randomized clinical trial, an oral presentation at DDW, June 2009
    Abstract PDF


  • Fidaxomicin (OPT-80) North American Phase 3 Top-line Data
    A randomised, double-blind clinical trial of OPT-80 versus vancomycin in Clostridium difficile infection, an oral presentation at the 19th ECCMID, May 2009
    Abstract PDF


  • OPT-80 Additional Phase 2A study on NAP1 %
    Typing and Susceptibility of Bacterial Isolates from the OPT-80 (PAR-101) Phase 2A Study for C. Difficile-associated Diarrhea, presented at the 9th Biennial Congress of the Anaerobe Society of the Americas, June 2008
    Poster PDF


  • OP-1118, active metabolite in OPT-80, in vitro activity
    Narrow Spectrum Activity and Low Fecal Binding of OPT-80 and Its Major Hydrolysis Metabolite (OP-1118), poster presented at the 47th ICAAC, an annual meeting of the American Society for Microbiology, September 2007
    Poster PDF


  • OPT-80 Additional Phase 2A study on Bacteroides count
    PAR-101 is selectively effective against Clostridium difficile in-vivo and has minimal effect on the anaerobic fecal flora, poster presented at the 45th ICAAC, an annual meeting of the American Society for Microbiology, December 2005
    Poster PDF


  • OPT-80 Phase 2A Bacteroides count
    OPT-80 Eliminates Clostridium difficile and Is Sparing of Bacteroides
    AAC publication


  • OPT-80 Phase 2A
    Clinical Outcomes, Safety, and Pharmacokinetics of OPT-80 in a
    AAC publication


  • OPT-80 Microbiology Study
    Effect of Inoculum, pH, and Cations on the In vitro Activity of OPT-80 vs. Clostridium difficile, poster presented at the 45th ICAAC, an annual meeting of the American Society for Microbiology, December 2005
    Poster PDF


  • OPT-80 Phase 1B/2A
    Safety, Pharmacokinetics and Outcomes of PAR-101 in Healthy Subjects and Patients with Clostridium difficile-Associated Diarrhea (CDAD), poster presented at the 45th ICAAC, an annual meeting of the American Society for Microbiology, December 2005
    Poster PDF


  • OPT-80 Phase 1A/1B
    Safety, Tolerance, and Pharmacokinetic Studies of OPT-80 in Healthy
    AAC publication


  • OPT-80 Phase 1A/1B study
    Safety and Pharmacokinetics of OPT-80 in Human Volunteers, poster presented at the 44th ICAAC, an annual meeting of the American Society for Microbiology, October 2004
    Poster PDF


  • OPT-80 PAE
    Antimicrobial Activity and Post-Antibiotic Effect (PAE) of OPT-80, a New Macrocyclic Compound, against Clostridium difficile, poster presented at the 44th ICAAC, an annual meeting of the American Society for Microbiology, October 2004
    Poster PDF


  • OPT-80 Resistance
    Resistance Development, Cross Resistance, and Synergy Studies of OPT-80, poster presented at the 44th ICAAC, an annual meeting of the American Society for Microbiology, October 2004
    Poster PDF


  • OPT-80 Pre-Clinical Toxicology Studies
    Safety and Pharmacokinetics of OPT-80, a novel antibiotic for treatment of Clostridium difficile associated diarrhea (CDAD), poster presented at the 44th ICAAC, an annual meeting of the American Society for Microbiology, October 2004
    Poster PDF