Norgine B.V. today announced that results from the PLENVU® Phase III MORA trial were published in ENDOSCOPY, a monthly peer-reviewed medical journal on behalf of the European Society of Gastrointestinal Endoscopy.
PLENVU® is the first low volume preparation to demonstrate superior colon cleansing efficacy versus MOVIPREP®, with comparable safety and tolerability.
The MORA trial, a European Phase III study in adults, was designed to evaluate the efficacy and safety of PLENVU® compared to MOVIPREP® using a 2-day evening / morning split-dosing regimen. PLENVU® was also tested as a 1-day morning only split-dosing regimen. The study met both of its primary endpoints:
Overall colon cleansing: when administered using a morning split dosing regimen, PLENVU® is superior to MOVIPREP® in achieving successful overall bowel cleansing success (97.3% vs. 92.2%,P=0.014, per protocol population)
Right colon cleansing: PLENVU® administered as either evening morning split dosing or morning only split dosing is superior to MOVIPREP® (32.3% and 34.4% vs. 15.9% , P<0.001 for both, per protocol population).
PLENVU® is approved in Europe and in the US. In Europe, PLENVU® is available through Norgine and in the US through its partner Salix Pharmaceuticals, Ltd. ("Salix"), a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc.
Norgine manufactures PLENVU® globally.
Notes to Editors:
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine's total net sales were EUR 345 million, up 17 per cent.
Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
Norgine specialises in gastroenterology, hepatology, cancer and supportive care.
Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit http://www.norgineventures.com .
NORGINE and the sail logo are trademarks of the Norgine group of companies.
PLENVU is a trademark of the Norgine group of companies.
[i.] Bisschops R et al. Colon cleansing efficacy and safety with 1L NER1006 versus 2L polyethylene glycol + ascorbate: a randomized Phase 3 trial. ENDOSCOPY. https://doi.org/10.1055/a-0638-8125
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