Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifamycin SV MMX · 1 trial · 1 indication
The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner: Step 1: Identify when the patient achieves Clinical Cure. Step 2: Moving backwards from this time, identify the time of the last unformed stool. Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (two matching tablets) orally twice daily for 3 days (72 hours) |
| Rifamycin SV MMX | EXPERIMENTAL | Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo (two matching tablets) orally twice daily for 3 days (72 hours). |
| Rifamycin SV MMX | DRUG | Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). |
Inclusion Criteria Patients were enrolled in the study only if they met all of the following criteria: 1. Male and female patients 18 years of age or older 2. Female and male patients of childbearing potential must have agreed to use an effective method of birth control (this method must have been...
Rifamycin SV MMX is an investigational small molecule being developed for the treatment of traveler's diarrhea, a gastrointestinal condition. It is designed to target bacteria that cause this illness. The drug is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
Rifamycin SV MMX is a small molecule antibiotic that works by targeting bacterial RNA polymerase, an enzyme essential for bacterial protein synthesis. By inhibiting this enzyme, the drug prevents bacteria from multiplying, which helps treat traveler's diarrhea. This mechanism is typical of the rifamycin class of antibiotics.
Rifamycin SV MMX is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of traveler's diarrhea.
Rifamycin SV MMX is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 3 trial has been completed, and the drug is being evaluated for the treatment of traveler's diarrhea.
Rifamycin SV MMX has one completed Phase 3 clinical trial registered as NCT01142089. This randomized, double-blind, placebo-controlled study enrolled 264 participants with traveler's diarrhea in Guatemala and Mexico. The trial was designed to evaluate the safety and efficacy of the drug for this condition.
Rifamycin SV MMX is a specific formulation of rifamycin, an antibiotic class. The MMX designation refers to a multi-matrix system that delivers the drug in a controlled manner. While it shares the active ingredient with other rifamycin drugs, this particular formulation is being developed specifically for traveler's diarrhea.