Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifaximin SSD once daily · 1 trial · 1 indication
A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 40 mg Rifaximin SSD once daily | EXPERIMENTAL | 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose |
| Cohort 2 40 mg Rifaximin SSD twice daily | EXPERIMENTAL | 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose |
| Cohort 3 80 mg Rifaximin SSD once daily | EXPERIMENTAL | 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose |
| Cohort 4 80 mg Rifaximin SSD twice daiy | EXPERIMENTAL | 80 mg Rifaximin sustained extended release (SER) rifaximin SSD twice daily (BID) and lactulose |
| Cohort 5 Placebo twice daily | EXPERIMENTAL | SSD placebo twice daily (BID) and lactulose |
| Name | Type | Description |
|---|---|---|
| 40 mg Rifaximin SSD once daily | DRUG | SSD once daily (QD) |
| 40 mg Rifaximin SSD twice daily | DRUG | SSD twice daily (BID) |
| 80 mg Rifaximin SSD once daily | DRUG | SSD once daily (QD) |
| 80 mg Rifaximin SSD twice daily | DRUG | SSD twice daily (BID) |
| Placebo | DRUG | Administered twice daily (BID) |
Inclusion Criteria: * Male or female age 18 to 75 years of age (inclusive) at the time of screening. * Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contracept...
Rifaximin SSD once daily is an investigational small molecule being studied for the treatment of overt hepatic encephalopathy (OHE), a serious complication of liver disease. It is being developed as a soluble solid dispersion tablet formulation of rifaximin, intended for once-daily dosing in combination with lactulose.
Rifaximin SSD once daily is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting clinical research on this formulation for the treatment of overt hepatic encephalopathy.
Rifaximin SSD once daily is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 2 trial evaluating the drug has been completed.
Rifaximin SSD once daily was evaluated in a completed Phase 2 clinical trial with the identifier NCT03515044. The study, titled "Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)," enrolled 71 participants in the United States.
Rifaximin SSD once daily is a soluble solid dispersion formulation of the antibiotic rifaximin. It is designed for once-daily dosing, whereas other rifaximin products may require different dosing schedules. The SSD formulation is being studied specifically for overt hepatic encephalopathy.