Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PAR-101/OPT-80 · 1 trial · 2 indications
Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Vancomycin |
| 2 | EXPERIMENTAL | PAR-101/OPT-80 |
| Name | Type | Description |
|---|---|---|
| PAR-101/OPT-80 | DRUG | capsules |
| Vancomycin | DRUG | Capsules |
Inclusion Criteria: * Males/females with CDAD * Females must use adequate contraception * Signed informed consent Exclusion Criteria: * Life-threatening CDAD * Toxic megacolon * Pregnant * Concurrent use of diarrheal agents * Participation in other trials
PAR-101/OPT-80 is an investigational small molecule being developed for the treatment of Clostridium infections, specifically Clostridium difficile-associated diarrhea (CDAD). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
PAR-101/OPT-80 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 3 clinical trials for the treatment of Clostridium difficile-associated diarrhea.
PAR-101/OPT-80 is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of Clostridium difficile-associated diarrhea. The drug has not been approved by the FDA and remains in clinical trials to evaluate its safety and efficacy.
PAR-101/OPT-80 has one completed Phase 3 clinical trial, identified as NCT00468728. This randomized, double-blind, active-controlled study compared PAR-101/OPT-80 to vancomycin for the treatment of Clostridium difficile-associated diarrhea. The trial enrolled 535 participants across multiple countries, including the United States, Belgium, Canada, France, Germany, Italy, Spain, Sweden, and the United Kingdom.
Yes, PAR-101/OPT-80 is the same drug as OPT-80. The name PAR-101/OPT-80 combines both designations for this investigational small molecule being developed by Merck & Company, Inc. for the treatment of Clostridium difficile-associated diarrhea.