Norgine and Its Partner Salix Announce the US Launch of PLENVU®

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Norgine B.V.

11 Sep, 2018, 12:00 GMT

AMSTERDAM, September 11, 2018 /PRNewswire/ --

  • In the US, PLENVU® is now available for prescription and offers same-day morning-of-colonoscopy and 2-day split-dosing regimens 
  • In Europe, PLENVU® is available through Norgine 

Norgine and its partner Salix Pharmaceuticals, one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced the US launch and availability of PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), a lower-volume (1L) polyethylene glycol based (PEG) bowel preparation for colonoscopy.

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PLENVU® approvals were based on three phase III clinical trials: NOCT, MORA and DAYB[1],[2],[3].

Colonoscopy is an effective method for colorectal cancer screening and has been shown to reduce both the incidence and mortality of colorectal cancer when applied in the general population. Inadequate precolonoscopy bowel cleansing reduces the diagnostic accuracy of colonoscopy, particularly for the detection of smaller lesions and sessile polyps. This may result in repeat procedures, thereby increasing costs and potentially delaying the initiation of treatment, and potentially increasing resource requirement.[4],[5],[6]

Norgine manufactures PLENVU® globally and commercialises the product through its infrastructure in Europe, Australia and New Zealand.

For further information on PLENVU®  in the EU go to https://www.expertiseincolonoscopy.com/plenvu


GL/PLV/0818/0094

References

[1] 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

[2] Schreiber, et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy 2019; 51: 1-16 https://doi.org/10.1055/a-0639-5070

[3] DeMicco MP, et al.  Gastrointest Endosc. 2018: 87(3):677-687

[4] Bechtold ML, Mir F, Puli SR et al. Optimizing bowel preparation for colonoscopy: a guide to enhance quality of visualization. Ann Gastroenterol 2016; 29: 137 - 146

[5] Brenner H, Stock C, Hoffmeister M. Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies. BMJ 2014; 348: g2467

[6] Baxter NN, Warren JL, Barrett MJ et al. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol 2012; 30: 2664 - 2669

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