Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 75 mg, 100 mg) |
Drug Class | mu-opioid receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Improvement in Global Symptoms and Bowel Movements in irritable bowel syndrome (IBS): Eluxadoline demonstrated a statistically significant effect in alleviating global symptoms of IBS, with a relative risk of 0.85 (95% CI 0.79-0.92, P < .01), and showed significant improvement in bowel movement frequency (SMD = -1.26, 95% CI -2.49 to -0.04, P < .05).
- Efficacy Across Different IBS Types (irritable bowel syndrome with diarrhea (IBS-D) and irritable bowel syndrome with mixed bowel habits (IBS-M)): Eluxadoline, along with alosetron, ramosetron, and rifaximin, was superior to placebo for IBS-D and IBS-M patients at 12 weeks, with alosetron ranking highest in overall efficacy for the Food and Drug Administration (FDA)-recommended composite endpoint (improvement in abdominal pain and stool consistency).
- Comparative Efficacy in Symptom Management: While eluxadoline showed strong effects on global IBS symptoms and abdominal pain, alosetron was most effective for composite symptom relief, and ramosetron was rated highest specifically for abdominal pain relief.
- Adverse Event Profile: Eluxadoline was associated with relatively few adverse events among opioid receptor modulators, showing a lower rate of constipation compared to other drugs in this class. However, constipation remained a common adverse effect across all drugs except rifaximin, which had the fewest reported adverse events.
- Comparative Safety: Eluxadoline had a safer profile than alosetron and ramosetron, both of which had significantly higher total adverse events when compared to placebo; rifaximin ranked highest for safety with the fewest adverse events among all evaluated drugs.
- Effectiveness and Safety Across IBS Subtypes: Studies included adults with IBS-D and IBS-M, showing the effectiveness of eluxadoline, alosetron, ramosetron, and rifaximin across these IBS subtypes, with varying efficacy and safety profiles. Alosetron and ramosetron had higher adverse event rates, while rifaximin ranked highest in safety.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Viberzi (eluxadoline) Prescribing Information. | 2024 | AbbVie Inc., North Chicago, IL |