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 being studied for the treatment of overt hepatic encephalopathy, a serious complication of liver disease. It is a small molecule therapeutic in the gastrointestinal area. The Phase 2 program evaluated it in combination with lactulose for patients with this condition.
Rifaximin SSD once daily is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is the sponsor behind the clinical program for this gastrointestinal asset.
Rifaximin SSD once daily is in Phase 2 development. It is an investigational therapy and is not approved for commercial use. The Phase 2 study has been completed, and no active trials are currently listed for this asset.
Rifaximin SSD once daily was evaluated in the Phase 2 trial NCT03515044, titled Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE). The trial enrolled 71 participants in the United States, was randomized and double blind, and has been completed.
The Phase 2 trial NCT03515044 was a randomized, double-blind, controlled study of Rifaximin SSD once daily plus lactulose in adults with overt hepatic encephalopathy. It enrolled 71 participants aged 18 years and older in the United States and has been completed.