50 mg of Olorinab significantly improves abdominal pain in Irritable Bowel Syndrome

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.

Further reading:

https://onlinelibrary.wiley.com/doi/10.1111/nmo.14539