RHB-102 improves stool consistency in patients with IBS-D
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In men and women with diarrhea-predominant irritable bowel syndrome, RHB-102 was an effective and safe treatment, according to the American Journal of Gastroenterology.
“[RHB-102], a once daily bimodal release formulation of ondansetron, significantly improved stool consistency in patients with IBS-D,” Terry F. Plasse, MD, from RedHill Biopharma in Tel Aviv, Israel, and colleagues wrote. “Abdominal pain and composite response were also improved, although the differences were not statistically significant in this relatively small study. Treatment appeared to work at least as well in men as in women.”
Plasse and colleagues identified patients with IBS-D based on Rome III criteria, Bristol Stool Scale 6 on 2 or more days, weekly, and average daily worst pain intensity 3/10 and randomly assigned them to RHB-102 (n = 75) or placebo (n = 51) once daily for 8 weeks. Overall stool consistency response for at least 4 out of 8 weeks served at the primary endpoint. Other endpoints included overall worst abdominal pain and overall composite response.
Study data showed the overall stool consistency response rate was 56% in patients who received RHB-102 and 35.3% in patients who received placebo (P = .036). Investigators reported that rates were similar between men and women. Overall pain response was 50.7% with RHB-102 and 39.2 % with placebo. The composite response rate was 40% in the RHB-102 group and 25.5% in the placebo group. The differences were not significant between groups.
According to the researchers, stool consistency response rates were enhanced in patients with baseline C-reactive protein above the median, with 59.5% in the RHB-102 group and 23.2% in the placebo group (P = .009).
“Overall rates of adverse events were similar, with a higher rate of constipation in RHB-102 patients (13.3% vs. 3.9%) that resolved rapidly on withholding treatment,” Plasse and colleagues wrote.
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