Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifaximin SSD IR · 1 trial · 1 indication
The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo tablets once daily. |
| Rifaximin SSD 40 mg IR tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 40 mg immediate release (IR) tablet once daily. |
| Rifaximin SSD 80 mg IR tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet once daily. |
| Rifaximin SSD 40 mg SER tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 40 mg sustained extended release (SER) tablet once daily. |
| Rifaximin SSD 80 mg SER tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 80 mg sustained extended release(SER) tablet once daily. |
| Rifaximin SSD 80mgIR/80mgSER tablet | EXPERIMENTAL | Rifaximin soluble solid dispersion (SSD) 80 mg immediate release (IR) tablet + rifaximin SSD 80 mg sustained extended release (SER) tablet once daily. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| Rifaximin SSD 40 mg IR tablet | DRUG | - |
| Rifaximin SSD 80 mg IR tablet | DRUG | - |
| Rifaximin SSD 40 mg SER tablet | DRUG | - |
| Rifaximin SSD 80 mg SER tablet | DRUG | - |
| Rifaximin SSD 80mgIR/80mgSER tablet | DRUG | - |
Inclusion Criteria: * Diagnosis of liver cirrhosis and documented ascites. * Model End Stage Liver Disease (MELD) score of at least 12, MELD Na of at least 12, or Child-Pugh B (score of 7 - 9). * If applicable, has a close family or other personal contacts who can provide continuing oversight to th...
Rifaximin SSD IR is an investigational small molecule being studied for the prevention of complications of early decompensated liver cirrhosis. It is a soluble solid dispersion tablet formulation of rifaximin, designed for use in patients with this gastrointestinal condition. The drug is currently in Phase 2 clinical development.
Rifaximin SSD IR is a rifamycin antibacterial agent that targets the gut microbiome. It works by inhibiting bacterial RNA synthesis, thereby reducing the growth of intestinal bacteria that contribute to the complications of liver cirrhosis, such as hepatic encephalopathy. This mechanism is relevant to its use in early decompensated liver cirrhosis.
Rifaximin SSD IR is being developed by Bausch Health Companies Inc., traded on the New York Stock Exchange under the ticker BHC. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the prevention of complications in patients with early decompensated liver cirrhosis.
Rifaximin SSD IR is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. A Phase 2 dose-ranging study has been completed to assess its effects in patients with early decompensated liver cirrhosis.
Rifaximin SSD IR has one completed Phase 2 clinical trial, identified as NCT01904409. This was a dose-ranging study of rifaximin soluble solid dispersion tablets for the prevention of complications of early decompensated liver cirrhosis. The trial enrolled 420 participants in the United States and Russia, and was randomized, double-blind, and placebo-controlled.
Rifaximin SSD IR is a specific formulation of rifaximin, known as a soluble solid dispersion (SSD). This formulation is designed to improve the drug's solubility and absorption compared to standard rifaximin tablets. It is being investigated for use in liver cirrhosis, whereas standard rifaximin is already approved for other indications.