Norgine's PLEINVUE(TM) / PLENVU® (NER1006) Receives Dutch Approval for Bowel Cleansing in Adults Prior to any Procedure Requiring a Clean Bowel

AMSTERDAM, November 28, 2017 /PRNewswire/ --


- PLENVU(R) is the first 1-litre PEG bowel preparation[i],[ii],[iii] 
- PLENVU(R) is superior to MOVIPREP(R) in providing high-quality cleansing in the colon
ascendens[1] - an important area for adenoma detection[iv]


Norgine B.V. today announced that The Medicines Evaluation Board (MEB) in the Netherlands has granted marketing authorisation for PLEINVUE(TM) for bowel cleansing in adults prior to any procedure requiring a clean bowel. The approval was granted under the European decentralised procedure, with the UK as reference state. Norgine anticipates further marketing approvals in Q4 2017 and 2018.

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PLENVU(R) (known as PLEINVUE(TM) in the Netherlands), is approved for use in Belgium, Denmark, Finland, Iceland, the Netherlands and in the UK. PLENVU(R) is available in the UK.

PLENVU(R) is a novel, low volume (1-litre) polyethylene glycol (PEG) 3350-based bowel preparation that has been developed by Norgine to provide whole bowel cleansing.

PLENVU(R) provides superior high-quality bowel cleansing efficacy (in at least one segment of the colon)  compared to two widely used alternative bowel preparations: sodium picosulfate and magnesium salt solution (CITRAFLEET(R)) and 2-litre PEG with ascorbate (MOVIPREP(R)).[v]

The approval was based on data from the Phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies NOCT, MORA, and DAYB.

Norgine manufactures PLENVU(R) and commercialises the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.

To view the media release in full go to http://www.norgine.com

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i. Bisschops R, et al. P0179. Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus standard 2L PEG with ascorbate in overnight or morning split-dosing administration: results from the phase 3 study MORA. UEG Journal 2016; 4(5S): A218 - A219.

ii. DeMicco MP Clayton LB, Pilot J et al.  Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastroentest Endosc 2017; Aug 10. pii: S0016-5107(17) 32172-7. doi: 10.1016/j.gie.2017.07.047. [Epub ahead of print].

iii. Schreiber, et al. P1266. Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB.  UEG Journal 2016; 4(5S) : A589-A590

iv. Lasisi F, et al. Expert Rev Gastroenterol Hepatol 2011; 5(6): 745-754.

v. Hassan C, Manning J, Amlani B, Epstein M. High Quality Colon Cleansing With Novel 1L PEG-Based Bowel Preparation NER1006 versus Current Alternatives: Post hoc Analysis of 1,521 Patients in 3 Randomized Phase 3 Trials. P1041. Presented at World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

Media contact: Isabelle Jouin, T: +44(0)1895-453643



Photo:
http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg




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