Post-hoc analysis of 3 phase III trials of Plenvu demonstrate high quality cleaning in bowel cleansing.- Norgine.

Norgine presented new data demonstrating the superior high-quality bowel cleansing efficacy (in at least one segment of the colon) of Plenvu (previously NER 1006) compared to two widely used alternative bowel preparations: sodium picosulfate and magnesium salt solution (CITRAFLEET) and 2-litre PEG with ascorbate (MOVIPREP). The post-hoc analysis of three phase III clinical trials - DAYB, MORA and NOCT - evaluated high-quality cleansing results (one segment with Boston Bowel Preparation Scale score 3 and all other segments scores more than 2). The results showed that Plenvu produced significantly higher rates of high quality cleansing: in the DAYB study compared to a sodium picosulfate and magnesium salt solution, using day-before dosing (11.6% vs. 2.9%); in the MORA study compared to 2-litre PEG with ascorbate using split dosing (PM/AM, 37.3%; AM/AM, 38.1% vs. 24.6%); Plenvu achieved similar high-quality cleansing results as a trisulfate solution in the NOCT study (32.6% vs. 35.1%).

Assessment of adequate cleansing (BBPS segmental score more than 2) in the overall colon and the right colon showed that Plenvu produced numerically higher results compared to all three alternative preparations. A separate post-hoc analysis of the DAYB, MORA and NOCT trials found a positive relationship between cleansing grade and improved lesion detection rates, suggesting that high-quality bowel cleansing may improve polyp and adenoma detection rates in the overall colon. The data were presented at the World Congress of Gastroenterology at the American College of Gastroenterology.