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


  • Fidaxomicin (OPT-80)
    Fact Sheet
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  • Fidaxomicin (OPT-80) 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
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  • Fidaxomicin (OPT-80) FDX vs. Vancomycin with CA's
    Effect of Concomitant Antibiotics on Treatment of Clostridium difficile (CDI) Infection with Fidaxomicin or Vancomycin
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  • 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
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  • Fidaxomicin (OPT-80) 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
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  • 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
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  • 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
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  • Fidaxomicin (OPT-80) 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
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  • Fidaxomicin (OPT-80) 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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