Endoscopy Publishes the Dayb Phase III Trial for Plenvu®(Ner1006), the First One Litre Peg Bowel Preparation[i]

AMSTERDAM, July 24, 2018 /PRNewswire/ --

• PLENVU^{[® ]}was as effective as sodium picosulfate and magnesium salt solution (CITRAFLEET^{[® ]}) at achieving overall bowel cleansing success
• PLENVU^{[® ]}demonstrated non-inferior 'high quality' cleansing of the right colon 
• PLENVU^{[® ]}  showed superior overall bowel cleansing success and superior 'high quality' cleansing of the right colon in the per protocol population  
• Visualisation of the ascending colon is important because adenomas and polyps in this area are often more difficult to see than those in other areas of the colon^[ii] 

Norgine B.V. today announced that results from the PLENVU^{[® ]} Phase III DAYB trial were published in ENDOSCOPY, a monthly peer-reviewed medical journal on behalf of the European Society of Gastrointestinal Endoscopy.

     (Logo: http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg )

The DAYB study is a European study that compared PLENVU^{[® ]} to a sodium picosulfate and magnesium salt solution using a 1-Day before split-dosing regimen in adults. The study met both primary endpoints.

• PLENVU^{[® ]}was as effective as sodium picosulfate and magnesium salt solution at achieving overall bowel cleansing success: 62% vs. 53.8%, P = 0.038 (LCL*: -0.5 %)
• PLENVU^{[® ]} demonstrated non-inferior 'high quality' cleansing of the right colon: 4.4% vs. 1.2%, P = 0.027, (LCL*: -5.6 %)
• PLENVU^{[® ]}showed superior overall bowel cleansing success: 68.0% vs. 57.5%, P = 0.023 and superior 'high quality' cleansing of the right colon 5.2% vs. 1.0%, P = 0.015, in the per protocol population.

Colonoscopy is an effective method for colorectal cancer screening and has been shown to reduce both the incidence and mortality of colorectal cancer when applied in the general population. Inadequate precolonoscopy bowel cleansing reduces the diagnostic accuracy of colonoscopy, particularly for the detection of smaller lesions and sessile polyps. This may result in repeat procedures, thereby increasing costs and potentially delaying the initiation of treatment, and potentially increasing resource requirement.^{[iii],[iv],[v]}

PLENVU^{[® ]} is approved in Europe and in the US. In Europe, PLENVU^{[® ]} is available through Norgine and in the US through its partner Salix Pharmaceuticals, Ltd. ("Salix"), a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc.

Norgine manufactures PLENVU^[®] globally.

* One side lower confidence limit

GL/PLV/0718/0090

References

i. Schreiber Stefan et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy 2019; 51: 1-16

https://doi.org/10.1055/a-0639-5070

ii. Clark B. et al. Yield of repeat forward-view examination of the right side of the colon in screening and surveillance colonoscopy. Gastrointest endosc 2016;(84(1): 126-132

iii. Bechtold ML, Mir F, Puli SR et al. Optimizing bowel preparation for colonoscopy: a guide to enhance quality of visualization. Ann Gastroenterol 2016; 29: 137 - 146

iv. Brenner H, Stock C, Hoffmeister M. Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies. BMJ 2014; 348: g2467

v. Baxter NN, Warren JL, Barrett MJ et al. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol 2012; 30: 2664 - 2669

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