The FDA approved Salix Pharmaceuticals' Plenvu lower-volume polyethylene glycol-based bowel preparation.
Here's what you should know.
1. The approval clears the way for physicians to offer patients the 1-liter colonoscopy prep solution.
2. According to recent studies, most patients rank bowel preparation as one of the biggest barriers to colon care. The majority of complaints centered on the large volume and the unpleasant taste of bowel prep solutions.
3. Salix believes the 1-liter preparation offering could eliminate such barriers.
4. The FDA based its approval on multiple phase 3 clinical trials. In each trial, primary endpoints were met, while Plenvu achieved non-inferior overall bowel cleansing success and an "excellent plus good" level of cleansing. Plenvu is also the only FDA-approved same-day split dosing solution.
5. Salix is a subsidiary of Valeant Pharmaceuticals.