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Next-Generation Preparation for Colonoscopies Receives FDA Approval

Lowest, total-volume preparation bowel cleanser available in U.S.

The FDA has approved Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution, Salix Pharmaceuticals, Ltd.), a lower-volume (1-L) polyethylene-glycol–based bowel preparation.

Colorectal cancer is the third leading cause of cancer-related deaths in women and the second leading cause in men in the United States. The American Cancer Society estimates that there are approximately 97,000 new cases of colon cancer and 43,000 new cases of rectal cancer each year. It is also shown that successful colorectal cancer screening can help save lives. 

According to patients' experiences and reported barriers to colonoscopy, most patients perceived the bowel preparation to be the most burdensome part of colonoscopy. Complaints regarding bowel preparation typically relate to the large volumes necessary to consume and the unpleasant taste. By reducing the volume of solution patients must consume for effective bowel cleansing to only 1 L of active solution, the manufacturer hopes to improve the patient colonoscopy preparation experience.

The approval was based on multiple phase 3 clinical trials, including the NOCT study, which compares Plenvu with a trisulfate bowel cleansing solution (Suprep [sodium sulfate, potassium sulfate, and magnesium sulfate, Braintree Laboratories, Inc.]) using a two-day split-dosing regimen in adults. Both primary endpoints were met, achieving noninferior overall bowel cleansing success and “excellent plus good” cleansing of the ascending colon. Plenvu is 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. In Europe, Plenvu is approved and available through Norgine.

Source: Valeant Pharmaceuticals International, Inc.; May 7, 2018.

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