Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 75 mg, 100 mg) |
Drug Class | mu-opioid receptor agonist |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
Latest News
Summary
- Viberzi (eluxadoline) is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- IBS Global Symptoms and Bowel Movement Frequency: A meta-analysis of 9 studies involving 4,156 patients showed that opioid receptor modulators, including eluxadoline, significantly improved IBS global symptoms (RR = 0.85, 95% CI = 0.79-0.92, P < 0.01) and reduced bowel movement frequency (SMD = -1.26, 95% CI = -2.49--0.04, P < 0.05). Improvements in stool consistency and quality of life were not statistically significant.
- Overall Response to Therapy in IBS-D or IBS-M: A network meta-analysis of 18 RCTs with 9,844 patients found all drugs, including eluxadoline, were superior to placebo at 12 weeks based on the FDA-recommended endpoint. Alosetron 1 mg twice daily was ranked highest for efficacy, followed by ramosetron and then eluxadoline.
- Comparison to Other Drugs: Alosetron 1 mg twice daily ranked first for efficacy based on the FDA-recommended composite endpoint, ramosetron 2.5 µg once daily ranked highest for abdominal pain relief, and rifaximin 550 mg three times daily was ranked first for safety, though it was less effective than alosetron and ramosetron.
- In IBS-C and IBS-D trials, active drugs were associated with higher rates of adverse events compared to placebo. Diarrhea and headache were more common in IBS-C trials, and constipation, nausea, and abdominal pain were more common in IBS-D trials.
- Rifaximin 550 mg three times daily was ranked highest for safety, with fewer adverse events compared to other drugs, while alosetron and ramosetron had significantly more adverse events compared to placebo.
- Significant adverse events were observed in both IBS-C (diarrhea, headache) and IBS-D (constipation, nausea, abdominal pain) trials when treated with active drugs, including eluxadoline and other opioid receptor modulators.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Viberzi (eluxadoline) Prescribing Information. | 2020 | Allergan USA, Inc., Madison, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Diarrhea. | 2022 | Gastroenterology |
Eluxadoline Versus Antispasmodics in the Treatment of Irritable Bowel Syndrome: An Adjusted Indirect Treatment Comparison Meta-analysis | 2022 | Frontiers in Pharmacology |
Evidence-based clinical practice guidelines for irritable bowel syndrome 2020. | 2021 | Journal of Gastroenterology |
Canadian Association of Gastroenterology clinical practice guideline for the management of irritable bowel syndrome (IBS). | 2019 | Journal of the Canadian Association of Gastroenterology |