50 mg of Olorinab significantly improves abdominal pain in Irritable Bowel Syndrome
USA: A study published in Neurogastroenterology and Motility has concluded that any dose of olorinab treatment for 12 weeks has no superiority to a placebo in reducing weekly average abdominal pain scores (AAPS) in Irritable bowel syndrome (IBS). However, a subgroup analysis has revealed 50 mg olorinab given TID improves AAPS in IBS-C participants with moderate-to-severe pain at baseline compared to placebo.
The prevalence rate of IBS is 4% and is characterized by recurrent abdominal pain with abnormal stool frequency and form. It has subtypes like IBS-D (diarrhoea), IBS-C (constipation) and IBS-M (mixed).
Abdominal pain impairs quality of life, and current pharmacological management is less effective for controlling abdominal pain. This aspect requires further investigation.
Olorinab is a peripherally acting full agonist of CB2. Studies have demonstrated that olorinab 25 mg or 100 mg three times improve abdominal pain scores in Crohn's disease.
Researchers presented the CAPTIVATE study, a randomized, double-blind, placebo-controlled, parallel-group trial evaluating Olorinab’s efficacy and safety for treating abdominal pain in IBS-D or IBS-C patients.
The study summary includes the following:
- 273 Patients received olorinab 10 mg (67 patients), 25 mg (67 patients), or 50 mg (69 patients) thrice daily or placebo (70 patients) TID for 12 weeks.
- Change in AAPS score was the primary endpoint from baseline to Week 12.
- The changes between placebo and any olorinab dose were non-significant.
- The prespecified subgroup analysis had baseline AAPS ≥6.5; olorinab 50 mg improved AAPS.
- No serious events were reported.
Olorinab is well-tolerated and improved weekly average abdominal pain scores (AAPS), but the primary endpoint was unmet.
Treatment with any dose of olorinab for 12 weeks was not superior to placebo in reducing weekly average abdominal pain scores in IBS. However, in a prespecified subgroup analysis, olorinab 50 mg TID did show a clinically meaningful and statistically significant improvement compared with placebo in abdominal pain scores in participants with moderate-to-severe pain at baseline (i.e., AAPS ≥6.5), with the improvement being predominately seen in participants with IBS-C. Future studies to evaluate olorinab efficacy in patients with IBS, particularly in those with moderate-to-severe abdominal pain, would be beneficial.
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