LONDON, May 6, 2017 /PRNewswire/ --
Norgine B.V. today presented new post-hoc analyses from the phase III DAYB and MORA studies that demonstrate the high-quality cleansing efficacy of PLENVU®, a low volume, 1 litre PEG and ascorbate bowel preparation when compared to sodium picosulfate with magnesium citrate (CITRAFLEET®) and 2 litre PEG with ascorbate (MOVIPREP®) respectively when using site colonoscopist assessments.[1],[2] In addition, data from the DAYB study show that PLENVU® achieved statistically significant improvements in adequate cleansing rates using the Boston Bowel Preparation Score when compared to sodium picosulfate with magnesium citrate.[3]
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High cleansing efficacy:
- In the DAYB study, when compared to sodium picosulfate with magnesium citrate (CITRAFLEET®) using a day before dosing, PLENVU® achieved significantly better cleansing success;
- in the overall colon (73.3% vs 60.9%, P=0.003)[1]
- and a high-quality cleansing of the ascending colon (36.3% vs 15.4%, P<0.001)[1]
- In the MORA study, when compared to standard 2 litre PEG with ascorbate (MOVIPREP®), PLENVU® achieved a significantly improved rate of;
- cleansing in the overall colon when administered as an evening/morning split-dose (97.0% vs 90.9%, P=0.003)[2]
- high-quality cleansing in the ascending colon when administered as an overnight split-dose (74.8% vs 60.9%, P<0.001) or morning-only dose (75.8% vs 60.9%, P<0.001)[2]
Improved cleansing (Boston Bowel Preparation Scale) in evening only dosing when compared to sodium picosulfate with magnesium citrate;
- PLENVU® achieved a statistically significantly increased proportion of adequate level cleansing of the overall (61.9% vs 47.3%, P=0.001) and ascending colon (66.9% vs 50.2%, P<0.001) in patients with Boston Bowel Preparation Scale scores[3]
PLENVU® has been shown to be well tolerated in studies versus standard 2 litre PEG with ascorbate, sodium picosulfate with magnesium citrate and trisulfate solution.[4],[5],[6]
Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented "These phase III data confirm the potential of PLENVU®, a low volume bowel preparation to replace standard bowel preparations. As colonoscopy is considered one of the most effective colorectal screening procedures, use of a highly efficacious bowel preparation such as PLENVU® is important to enable better detection of adenomas and polyps which ultimately will improve patients outcomes and save healthcare systems resources."
These data were presented at Digestive Diseases Week, 6-9 May 2017, Chicago.
The PLENVU® Phase III clinical trial programme includes three multicentre, randomised, parallel group studies: NOCT, MORA, and DAYB.
Colorectal cancer is the second most common cause of cancer-related mortality in Europe and the US, with 412,000 new diagnoses of colorectal cancer every year in Europe and 136,115 in the US.[7],[8]
PLENVU® data being presented at DDW on Saturday 6 May, 12:00 CDT
- Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. Poster Sa1096
- Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. Poster Sa1109
- Achieving adequate level bowel preparation with evening only dosing of novel NER1006 versus sodium picosulfate + magnesium citrate: post-hoc analysis from a randomized controlled trial. Poster Sa1120
- High cleansing efficacy of NER1006 also in the elderly; subgroup analysis of randomized phase 3 trials. Poster Sa1110
In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for PLENVU® in the US and Canada.
PLENVU®is not yet approved for use in the US or Europe. Norgine anticipates regulatory approval in Europe in 2017 and in 2018 in the US.
View the full release on http://www.norgine.com
1. Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, 6-9 May 2017
2. Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, 6-9 May 2017
3. Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, 6-9 May 2017
4. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 - A219
5. DeMicco M, et al. OP375 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. UEG Journal 2016; 4(Suppl1): A415-A416
6. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L 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(Suppl1): A589-A590
7. Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915
8. Colorectal Cancer Statistics 2013. Centers for Disease and Control and Prevention. https://www.cdc.gov/cancer/colorectal/statistics/ [Accessed 25 April 2017]
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