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Press Release

Positive US Phase III Data Show Efficacy of PLENVU™ (NER1006), a Low Volume, PEG Based Bowel Cleansing Solution

Norgine B.V.
Posted on: 19 Oct 16

PR Newswire

LONDON, October 19, 2016

LONDON, October 19, 2016 /PRNewswire/ --

Norgine B.V. today presented positive phase III data from the US based, NOCT study that compares the bowel cleansing efficacy of PLENVU™ (NER1006) versus trisulfate bowel cleansing solution (SUPREP®) in patients undergoing colonoscopy. The study met its primary endpoints demonstrating that when administered as a 2-day split-dosing regimen, PLENVU™ was non-inferior in overall bowel cleansing success. It also achieved an 'Excellent plus Good' cleansing rate in the ascending colon.[1]

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These data were presented at United European Gastroenterology Week (UEGW) 2016.

PLENVU™ has been developed to provide overall bowel cleansing in adults, with an additional focus on the ascending colon. Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps. 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. [2]

PLENVU™ demonstrated an acceptable safety profile in overnight split-dosing administration.

The PLENVU™ Phase III clinical trial programme includes three multicentre randomised parallel group studies: NOCT, MORA, and DAYB.  

In the US, colorectal cancer is the fourth most common cause of cancer-related mortality, with 136,119 people diagnosed in 2013.[3],[4] In Europe, colorectal cancer is the second most common cause of cancer-related mortality, with 412,000 new diagnoses of colorectal cancer diagnosed every year.[5]

Dr Alastair Benbow, Chief Development & Medical Officer, at Norgine said, "These data are significant for patients because PLENVU™ can enhance the detection of adenomas and polyps that frequently go undetected and often result in colorectal cancer. Improving the quality of screening, will ultimately lead to better patient outcomes and can help reduce healthcare costs."

He added, "As a novel and the only 1 litre solution, PLENVU™ addresses the challenges faced by patients to comply with drinking higher volume, 2 and 3 litre, preparations."

PLENVU™ is not yet approved for use.

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1. Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: Results from the phase 3 study NOCT. Abstract 1242. UEGW 2016.

2. Brenner H et al. Protection From Right- and Left-Sided Colorectal Neoplasms After Colonoscopy: Population-Based Study. J Natl Cancer Inst 2010;102:89-95

5. Zavarol WJ, et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009. 15(47): 5907-5915

Norgine Media Contacts
Isabelle Jouin, T: +44(0)1895-453643
Charlotte Andrews, T: +44(0)1895-453607
Follow us @norgine

PR Newswire

Last updated on: 19/10/2016

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