Lower-Volume Colonoscopy Preparation Solution Gets FDA Approval

The US Food and Drug Administration (FDA) has approved a lower-volume polyethylene glycol based (PEG) bowel preparation (PLENVU).

PLENVU — an oral solution of polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride — is produced by Salix Pharmaceuticals. With its approval, it becomes the lowest total-volume preparation bowel cleanser available in the US, and the only FDA-approved bowel cleaning to offer split dosing on the same day as colonoscopy procedure.

The solution’s approval is based on the results of multiple phase 3 clinical trials, including the NOCT study — a comparative study of PLENVU versus a trisulfate bowel cleansing solution (SUPREP) in 2-day split dosing regimen in adult patients. The solution met primary endpoints for non-inferior overall bowel cleansing success, as well as “excellent plus good” cleansing metrics of the ascending colon.

A majority of patients perceive bowel preparation to be the most burdensome stage of colonoscopies, according to Salix, with complaints generally relating to the large volumes of solution needed to be taken and its poor taste. The benefit of PLENVU comes in its reduced volume at 1 liter, which the company hopes will improve patient colonoscopy preparation experience.

"With the FDA approval of PLENVU, physicians can now offer their patients a new preparation option for colonoscopies that features a lower-volume, one-liter PEG bowel preparation," Mark McKenna, senior vice president and general manager, Salix Pharmaceuticals, said in a statement. "Studies have shown that high-volume bowel preparations can often be a deterrent to patients fully completing their preparation regimen.”

Philip Schoenfeld, MD, MEd, MSc, of the Institute for Healthcare Policy & Innovation, University of Michigan, said the solution only serves to improve the “gold standard” screening method for diseases such as colon cancer.

“With today's approval, we have a next-generation, one liter low volume option while still providing adequate and effective cleansing," Schoenfeld said.

PLENVU is expected to be available in US markets in the third quarter of 2018.