Low-Volume Colonoscopy Prep Product Approved

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May 21, 2018
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The US Food and Drug Administration has approved a low-volume product for bowel cleansing product for colonoscopy preparation.  The new product, Plenvu® (Salix Pharmaceuticals) is an osmotic laxative that contains polyethylene glycol (PEG) 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride.  The new product is diluted by the patient to a volume of 1 liter volume, which is considerably lower than the current alternative products which require patients to consume 3-4 liters of fluid. 

Colorectal cancer is the third leading cause of cancer-related deaths in women and the second leading cause in men in the US.  Colonoscopy is the gold standard for colorectal cancer screening.  Patients commonly complain about the large volume and unpleasant taste of bowel prep products as the reason for avoiding screening colonoscopy.  A lower-volume product has the potential to reduce the challenges of preparing for screening, increasing screening rates.  In clinical trials, Plenvu® has been shown to be as effective as a 3 liter sodium, potassium and magnesium sulfate prep product (Suprep®) as well as a 2 L PEG product (Moviprep®).

Plenvu® is currently the only product approved for use on the same day as the colonoscopy (versus use the evening before the procedure or as a split regimen, administering half the evening before and the remainder the morning of the procedure).  This advantage reduces the amount of time patients must be in fasting state prior to procedures and may allow greater flexibility in procedure scheduling (both common deterrents to successful colorectal cancer screening).

Additional information about PEG 3350 osmotic laxatives can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Top 300 Pharmacy Drug Cards.  If your institution does not provide access, ask your medical librarian about subscribing.

 


Information about colorectal cancer rates and screening can be found at the American Cancer Society web site: https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html

Clinical trials regarding Plenvu®:

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. Gastrointest Endosc. 2017;87(3):677-687.

Bisschops R, Manning J, Clayton L, Shing RNK, Alvarez-Gonzalez MA.  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 [abstract TU2087].  Gastroenterology.  2016;150(4, Suppl 1):s1269-s1270.

Go to the profile of Lee C. Vermeulen

Lee C. Vermeulen

Professor of Medicine and Pharmacy, University of Kentucky

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