The Food and Drug Administration (FDA) has approved Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution; Salix), a low-volume (1 liter) polyethylene glycol based bowel preparation for use prior to colonoscopy.
The approval of Plenvu was based on multiple clinical trials including the NOCT study which compared Plenvu to the trisulfate bowel cleansing solution Suprep (sodium sulfate, potassium sulfate, magnesium sulfate oral solution; Braintree Laboratories) using a 2-day evening/morning split-dosing regimen. Results assessed by a blinded colonoscopist using the Harefield Cleansing Scale showed that 235 out of 276 participants in the Plenvu group had successful bowel cleansing compared with 238 out of 280 in the Suprep group. In addition, 99 participants in the Plenvu group were found to have ‘high-quality’ cleansing of the ascending colon compared with 82 in the Suprep group.
“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,” said Mark McKenna, senior vice president and general manager, Salix Pharmaceuticals. “Studies have shown that high-volume bowel preparations can often be a deterrent to patients fully completing their preparation regimen. In contrast, Plenvu is the lowest, total-volume preparation bowel cleanser available in the United States.”
Plenvu will be available in the US during the third quarter of 2018.
For more information call 866-246-8245 or visit Salix.com.