Drug/Device Pipeline

FDA Approves Low-volume Colonoscopy Prep Plenvu

The FDA has approved Plenvu as a pre-colonoscopy cleansing preparation, according to a press release from Salix Pharmaceuticals.

Plenvu (NER1006) is a low-volume glycol-based bowel preparation developed for whole-bowel cleansing, with a focus on the ascending colon. It will have the lowest total volume of any bowel preparation currently available in the United States, according to the press release.

“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 [polyethylene glycol based] bowel preparation,” Mark McKenna, senior vice president and general manager of Salix Pharmaceuticals said in the press release. “Studies have shown that high-volume bowel preparations can often be a deterrent to patients fully completing their preparation regimen.”

The approval was based on several phase 3 trials, according to the press release. One, the NOCT trial, tested Plenvu against a trisulfate bowel cleansing solution using a two-day split-dosing regimen in adults. Plenvu achieved both primary endpoints of the trial by producing non-inferior overall bowel cleansing success and “excellent plus good” cleansing of the ascending colon, according to the press release.

Salix — which licensed Plenvu from Norgine B.V. in 2016 — expects the product to be available in the U.S. in the third quarter of 2018.

Disclosures: McKenna is employed by Salix.

The FDA has approved Plenvu as a pre-colonoscopy cleansing preparation, according to a press release from Salix Pharmaceuticals.

Plenvu (NER1006) is a low-volume glycol-based bowel preparation developed for whole-bowel cleansing, with a focus on the ascending colon. It will have the lowest total volume of any bowel preparation currently available in the United States, according to the press release.

“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 [polyethylene glycol based] bowel preparation,” Mark McKenna, senior vice president and general manager of Salix Pharmaceuticals said in the press release. “Studies have shown that high-volume bowel preparations can often be a deterrent to patients fully completing their preparation regimen.”

The approval was based on several phase 3 trials, according to the press release. One, the NOCT trial, tested Plenvu against a trisulfate bowel cleansing solution using a two-day split-dosing regimen in adults. Plenvu achieved both primary endpoints of the trial by producing non-inferior overall bowel cleansing success and “excellent plus good” cleansing of the ascending colon, according to the press release.

Salix — which licensed Plenvu from Norgine B.V. in 2016 — expects the product to be available in the U.S. in the third quarter of 2018.

Disclosures: McKenna is employed by Salix.