AMSTERDAM, October 16, 2017 /PRNewswire/ --
Norgine B.V. today presented new data demonstrating the superior high-quality bowel cleansing efficacy (in at least one segment of the colon) of PLENVU(R) (NER1006) compared to two widely used alternative bowel preparations: sodium picosulfate and magnesium salt solution (CITRAFLEET(R)) and 2-litre PEG with ascorbate (MOVIPREP(R)). The data were presented at the World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA. PLENVU(R) is a novel 1-litre polyethylene glycol (PEG)-based bowel preparation currently under regulatory review in the US and EU.
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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 >2). The results showed that PLENVU(R) 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%; p<0.01)
- 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%, both p<0.01).
PLENVU(R) achieved similar high-quality cleansing results as a trisulfate solution in the NOCT study (32.6% vs. 35.1%, p=0.63). Assessment of adequate cleansing (BBPS segmental score >2) in the overall colon and the right colon showed that PLENVU(R) 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.
Dr Cesare Hassan of the Nuovo Regina Margherita Hospital, Rome, Italy said, "These results confirm that PLENVU(R) achieves consistent excellent bowel cleansing, with lower volume intake, compared to widely used alternative preparations. Combined with the finding that better cleansing may improve polyp and adenoma detection, PLENVU(R) has the potential to improve outcomes and save healthcare resources."
He added, "The very high quality of the PLENVU(R) studies emphasise that these results are robust and irreversible."
Isabelle Jouin, T: +44(0)1895-453643 Charlotte Andrews, T: +44(0)1895-453607
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