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 developed by Bausch Health Companies Inc. for liver cirrhosis. It is a soluble solid dispersion immediate-release tablet formulation studied for the prevention of complications of early decompensated liver cirrhosis. It is not an approved product and remains in clinical development.
Rifaximin SSD IR was studied for the prevention of complications of early decompensated liver cirrhosis. The Phase 2 program evaluated whether the soluble solid dispersion immediate-release tablet could reduce cirrhosis-related complications in adults. The indication is liver cirrhosis, within the gastrointestinal therapeutic area.
Bausch Health Companies Inc., which trades under the ticker BHC, is the developer of Rifaximin SSD IR. The company sponsored the clinical program evaluating this soluble solid dispersion immediate-release rifaximin tablet in liver cirrhosis.
Rifaximin SSD IR is in Phase 2 development. It is an investigational agent and has not been approved for any indication. The Phase 2 program has been completed, and no trials of this formulation are currently active.
Rifaximin SSD IR was evaluated in the Phase 2 trial NCT01904409, titled a dose-ranging study of rifaximin soluble solid dispersion tablets for the prevention of complications of early decompensated liver cirrhosis. The completed trial enrolled 420 adults across the United States and Russia and was randomized, double-blind, and placebo-controlled.