Approval Probability
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Label indication To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. FDA label
Also known as Low Dose Rifaximin ER, Low Dose Rifaximin, Rifaximin (Xifaxan), open-label rifaximin, double-blind rifaximin, Xifaxan®
rifaximin · 11 trials · 7 indications
Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.
The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? \[Yes/No\]"
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time to a breakthrough overt HE episode was the duration (number of days) from time of first dose of study drug to the first breakthrough overt HE episode. A breakthrough overt HE episode was defined as an increase of Conn score from Grade 0 or 1 to ≥2, or an increase in Conn and asterixis score of 1 grade each for those participants who entered the study with a Conn score of 0. Participants who completed the study and did not experience a breakthrough overt HE episode were censored at the time of their 6-month visit. Participants who terminated early for reasons other than a breakthrough overt HE episode were contacted at 6 months from randomization to determine if they had experienced a breakthrough overt HE event or other outcome. Participants without breakthrough overt HE were censored at the time of last contact or death, whichever was earlier. The number of events of a first breakthrough overt HE episode during the treatment interval is presented.
Resolution or improvement of baseline signs and symptoms was assessed as * Absence of severe abdominal pain for 2 consecutive days at the test of cure (TOC) Visit (Day 14 +/-1); * Absence of fever (\< 38°C/100.4°F) for 2 consecutive days at the TOC Visit; and * 3 unformed (loose or watery) stools per day for at least 48 hours that was sustained through the TOC Visit.
The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.
Maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| Rifaximin open-label | EXPERIMENTAL | Subjects will receive open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders will continue into Maintenance Phase 1 (treatment free). Nonresponders will withdraw from the study. Subjects who meet criteria for recurrence in Maintenance Phase 1 enter the double-blind period and are randomized 1:1 to receive rifaximin 550 mg or placebo. |
| Double-blind rifaximin (retreatment) | EXPERIMENTAL | Subjects in this arm receive rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. |
| Double-blind placebo (retreatment) | PLACEBO_COMPARATOR | Subjects in this arm receive placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks \[treatment free\]) followed by a second retreatment with placebo TID for 2 weeks with a 4-week treatment-free follow-up. |
| Placebo | PLACEBO_COMPARATOR | Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. |
| Rifaximin | EXPERIMENTAL | Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. |
| Rifaximin Treatment Arm | EXPERIMENTAL | rifaximin 400mg taken 3 times a day |
| Vancomycin Comparator Arm | ACTIVE_COMPARATOR | vancomycin 125mg taken 4 times a day |
| 1 | ACTIVE_COMPARATOR | Rifaximin |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Low Dose Rifaximin ER | EXPERIMENTAL | twice daily |
| Low Dose Rifaximin DER | EXPERIMENTAL | twice daily |
| High Dose Rifaximin ER | EXPERIMENTAL | twice daily |
| High Dose Rifaximin DER | EXPERIMENTAL | twice daily |
| Name | Type | Description |
|---|---|---|
| open-label rifaximin | DRUG | 550 mg three times a day (open-label) |
| double-blind placebo | DRUG | 3 times a day (double-blind) |
| double-blind rifaximin | DRUG | 550 mg three times a day (double-blind) |
| Rifaximin | DRUG | - |
| Placebo | DRUG | - |
| Rifaximin (Xifaxan) | DRUG | - |
| Vancomycin | DRUG | - |
| Low Dose Rifaximin ER | DRUG | Low Dose Rifaximin Extended Release Twice Daily |
| Low Dose Rifaximin DER | DRUG | Low Dose Rifaximin Delayed Extended Release Twice Daily |
| High Dose Rifaximin ER | DRUG | High Dose Rifaximin Extended Release Twice Daily |
| High Dose Rifaximin DER | DRUG | High Dose Rifaximin Delayed Extended Release Twice Daily |
Inclusion Criteria: * IBS confirmed by Rome III diagnostic criteria. * At least 18 years of age. * Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if \< 50 years of age or previous colonoscopy \> 10 years prior. * Willing to maintain a stable d...
Rifaximin is studied for several gastrointestinal and infectious conditions, including irritable bowel syndrome with diarrhea, non-constipation irritable bowel syndrome, travelers' diarrhea, hepatic encephalopathy, and Clostridium infections. It is a small molecule developed by Bausch Health Companies Inc. under the ticker BHC. The program includes Phase 3 trials in diarrhea and IBS-related indications.
Rifaximin is developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company sponsors the clinical program, including Phase 3 studies in irritable bowel syndrome with diarrhea and travelers' diarrhea, and a Phase 2 study in sickle cell disease.
Rifaximin is in Phase 3 clinical development. The program includes completed Phase 3 trials in irritable bowel syndrome with diarrhea, non-constipation irritable bowel syndrome, and travelers' diarrhea, plus a completed Phase 2 pharmacokinetics and pharmacodynamics study in sickle cell disease. No active trials are currently listed for this program.
Rifaximin has been studied in several completed trials, including NCT01543178, a Phase 3 IBS-D re-treatment study enrolling 2,583 patients; NCT00731679, a Phase 3 trial in non-constipation IBS with 623 patients; NCT00742469, a Phase 3 travelers' diarrhea prevention study with 210 patients; and NCT05098028, a Phase 2 sickle cell disease study with 44 patients.
Rifaximin is also referred to as Low Dose Rifaximin ER, Low Dose Rifaximin, Rifaximin (Xifaxan), and open-label rifaximin. These names refer to the same small molecule program developed by Bausch Health Companies Inc. for gastrointestinal and infectious disease indications.
Rifaximin is being developed for irritable bowel syndrome, including irritable bowel syndrome with diarrhea and non-constipation irritable bowel syndrome. Phase 3 trials have evaluated the drug in these populations, including a 2,583-patient IBS-D re-treatment study and a 623-patient non-constipation IBS study.