7 May 2018 - Salix Pharmaceuticals and its partner Norgine announced today that the U.S. FDA has approved Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulphate, ascorbic acid, sodium chloride and potassium chloride for oral solution), a lower-volume  polyethylene glycol based bowel preparation.

The approval was based on multiple Phase 3 clinical trials, including the NOCT study, which compares Plenvu versus a trisulfate bowel cleansing solution (Suprep) using a two-day split-dosing regimen in adults. Both primary endpoints were met, achieving non-inferior overall bowel cleansing success and 'Excellent plus Good' cleansing of the ascending colon. Plenvu is also the only FDA-approved bowel cleanser to offer split dosing on the same day as the colonoscopy procedure.

Plenvu was licensed by Salix from Norgine in August 2016 for introduction to the U.S. market and will be available in the U.S market in the third quarter of 2018.

Read Valeant Pharmaceuticals press release