New bowel-prep formula cleans the colon with lower fluid volume

Last Updated: 2017-09-01

By Will Boggs MD

NEW YORK (Reuters Health) - A new 32-ounce polyethylene glycol-based bowel preparation, NER1006, provides adequate colon cleansing and reduces overall fluid intake by 32 ounces, according to a new study.

"This prep is far better than the standard in (terms of) ease to patient and quality of prep," Dr. Michael P. DeMicco from Associated Gastroenterology Medical Group, Anaheim, California, told Reuters Health by email. "I think it could be a standard of care; however, there will undoubtedly be other challenger preps in the future."

Standard split-dose bowel preparations require patient consumption of up to 4 liters, thereby making it less tolerable to patients, reducing adherence, and resulting in poorer cleansing. Newer formulations allow lower volumes, but patients still may have to drink 2 liters of reconstituted solution plus 1 liter of additional clear fluids.

In contrast, NER1006 requires two 32-ounce doses, totaling about 32 ounces less than currently used formulations.

Dr. DeMicco and colleagues assessed bowel-cleansing efficacy, safety, and tolerability of an evening/morning split-dosing regimen of either NER1006 (16 ounces of NER1006 plus 16 ounces of water each dose) or trisulfate bowel preparation (16 ounces of trisulfate plus 32 ounces of water each dose) in their phase 3 study of 556 patients from 12 U.S. centers.

The report was published online August 10 in Gastrointestinal Endoscopy.

Rates of overall cleansing success were nearly identical in the two groups - 85.1% with NER1006, 85.0% with trisulfate - thereby meeting the criteria for noninferiority of NER1006.

High-quality cleansing of the ascending colon/cecum tended to be better with NER1006 than with trisulfate (36% vs. 29% of patients; P=0.059).

Adenoma-detection rates in the ascending colon/cecum did not differ significantly between the NER1006 (14.1%) and trisulfate (17.1%) groups.

Patient diary responses indicated better tolerability of NER1006 than trisulfate, but treatment-related adverse events were more common in the NER1006 group (14.9% vs. 9.4%). Overall adherence was high and similar between treatment groups.

Norgine Ltd., which has outlicensed NER1006 to Salix Pharmaceuticals, Ltd., funded the trial and employed 2 of the 4 authors. In June 2017, the companies announced that the US FDA had accepted their New Drug Application for NER1006. (http://www.norgine.com/press_release/norgine-announces-fda-filing-acceptance-for-plenvu-ner1006/)

SOURCE: http://bit.ly/2wqOUd8

Gastrointest Endosc 2017.