Navigation Links
New Positive Phase III Study for NER1006 - The First 1 Litre PEG-Based Bowel Preparation

LONDON, May 24, 2016 /PRNewswire/ --


  • Study met both primary endpoints demonstrating non-inferiority in overall bowel cleansing and superiority in 'Excellent plus Good' cleansing of the ascending colon 

     (Logo: )

Norgine B.V. today announced new positive data from the phase III MORA study for NER1006 (1 litre PEG and ascorbate bowel preparation) versus standard 2 litre PEG with ascorbate. The study met both primary endpoints showing that when administered as either a 2-day overnight or 1-day morning split-dosing regimen, and compared to 2L PEG, NER1006 was:

  • Non-inferior in achieving overall bowel cleansing
  • Non-inferior and superior in achieving 'Excellent plus Good' cleansing of the ascending colon

In addition, the study showed that as a 2-day overnight or 1-day morning split-dosing regimen, NER1006 was non-inferior in detecting adenomas and polyps in the ascending and overall colon and as a 2-day overnight split-dosing regimen, it demonstrated a superior polyp detection rate in the ascending colon.

The overall tolerability and safety profile of NER1006 was comparable to that of 2L PEG. Treatment related adverse events were mild or moderate in severity and reflected the expected safety profile of the respective treatments.

The threshold for statistical significance in this study was P<0.025 and a 10% margin was used to demonstrate non-inferiority vs. 2L PEG. [1]

Peter Martin, Norgine's Chief Operating Officer, said: "The new positive phase III MORA results for NER1006 are promising because we know that the quality of a bowel preparation is an important factor for a successful colonoscopy and detecting polyps and tumours. These data reinforce Norgine's leadership in colonoscopy to provide patients with innovative treatments."

NER1006 is not yet approved for use. Norgine intends to submit NER1006 for approval in the US and EU.

The data was presented at Digestive Disease Week on 24 May 2016, 09:30-16:30.

To view the full press release go to


1. Raf Bisschops, Jonathan Manning, Lucy Clayton, Richard Ng Kwet Shing, Marco A. Alvarez-Gonzalez (2016): 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. Gastroenterology, Vol. 150, Issue 4, S1269-S1270. Abstract Tu2084. 


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

SOURCE Norgine B.V.
Copyright©2016 PR Newswire.
All rights reserved

Related medicine technology :

1. PharmaMar Reports Positive Results from the Phase I Study of plitidepsin in Combination with bortezomib and dexamethasone in Patients with Multiple Myeloma at the 2016 ASCO Annual Meeting
2. Oramed Announces Positive Top-Line Results from Phase IIb Oral Insulin Study
3. Breast Pumps Outlook Remain Positive, Sleek, Smart to Dominate the Market: Future Market Insights (FMI)
4. Celsion Corporation Announces Positive Data from the First Cohort of Patients in the OVATION Study
5. Oasmia Pharmaceutical Announces Positive Overall Survival Results From Phase III Study of Apealea/Paclical for Treatment of Ovarian Cancer
6. NICE Provides Positive Guidance on electroCores gammaCore Treatment for the Prevention and Acute Treatment of Migraine and Cluster Headache
7. Sylentis Reports Positive Phase II Results With SYL1001 in Treating Ocular Pain Related to Dry Eye Syndrome
8. Alexza Pharmaceuticals Receives Positive Nasdaq Listing Determination
9. ContraVir Pharmaceuticals Reports Positive Results Confirming the Safety of its Shingles Candidate FV-100 in a Drug-Drug Interaction Study
10. 2016 HIMSS Connected Health Survey Suggests Positive Future for Connected Health Technologies in U.S. Hospitals
11. scPharmaceuticals Announces Positive Results from Pivotal Trial of Second Program - Subcutaneous Ceftriaxone for Treatment of Bacterial Infections
Post Your Comments:
(Date:6/2/2017)... , June 2, 2017  NxStage Medical, Inc. (Nasdaq:  NXTM), a ... today announced new findings demonstrating positive biochemical outcomes related ... System One™. The data will be presented at the ... Madrid, Spain . The ... Home Dialysis Network in Europe ...
(Date:5/29/2017)... Israel, May 29, 2017  Cellect Biotechnology Ltd. (NASDAQ: ... technology which enables the functional selection of stem cells, ... for the first quarter ended March 31 st , ... our accomplishments in the first quarter of 2017," said ... quarter, we announced the treatment of the first blood ...
(Date:5/22/2017)... 2017  Lilac Corp, the company that sells ... of a new website . The website ... clinical study that showed surprising clearance of the ... individuals suffering from HPV warts, precancerous, or cancerous ... no other treatments that clear the virus. Specifically, ...
Breaking Medicine Technology:
(Date:6/20/2017)... ... June 20, 2017 , ... ... the introduction of school choice can promote economic development in economically distressed urban ... has, according to the report, contributed to the economic development of the city ...
(Date:6/20/2017)... ... June 20, 2017 , ... ... solutions for the enterprise, is proud to announce Touchpoints integrations. MindTouch ... systems, company websites, and more to provide a seamless customer experience. , Truly ...
(Date:6/20/2017)... ... 20, 2017 , ... As a leading dental practice, Wall Centre Dental supports ... disease. Those with bleeding gums in Vancouver, BC, may be developing gingivitis, the first ... heart disease, stroke and diabetes. Drs. Parviz Roshan, Siamak Tehrani and Milton Reskovich offer ...
(Date:6/20/2017)... ... June 20, 2017 , ... This year, ... focused on finding product improvements that could reduce the occurrence of unplanned ... they need help breathing or to provide medication. Sometimes, patient movement can cause ...
(Date:6/20/2017)... ... 20, 2017 , ... Uniform Advantage (UA), a multi-channel retailer of ... to create tailored looks and athleisure-inspired outfits. UA Flex fabric is breathable, wrinkle resistant ... , With trendy looks hitting the medical community, UA Flex is for the medical ...
Breaking Medicine News(10 mins):