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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
Posted on: 19 Oct 16

London, UK. Wednesday 19 October 2016, 11:00 BST. 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.[i]

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. [ii]

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.[iii],[iv] 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.[v]

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.

Other data presented at UEGW included:

  • Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation PLENVU (NER1006) versus standard 2L PEG with ascorbate in overnight or morning split-dosing administration: Results from the phase III study MORA. P0179, 17 October 2016, 10:30 - 17:00.
  • Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation PLENVU (NER1006) versus sodium picosulfate + magnesium citrate in day before split-dosing administration: Results from the phase 3 study DAYB. P1266, 19 October 2016, 09:00-14:00.
Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 19/10/2016

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