FDA Approves Smaller, 1-Liter Bowel Prep for Colonoscopies

Marcia Frellick


May 07, 2018

The US Food and Drug Administration (FDA) today approved a lower-volume, 1-liter bowel cleansing preparation for colonoscopies. The product is intended to reduce one of the biggest deterrents for patients in completing the preparation, according to a company press release.

Approval went to Salix Pharmaceuticals, Ltd, for its Plenvu next-generation product. Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a polyethylene glycol-based (PEG) preparation.

It is expected to be available in the United States in the third quarter of this year.

Mark McKenna, senior vice president and general manager of Salix Pharmaceuticals, said in the release, "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."

Colorectal cancer is the third leading cause of cancer-related deaths in women in the United States and is the second leading cause in men. The American Cancer Society estimates that there are about 97,000 new cases of colon cancer and 43,000 new cases of rectal cancer every year.

Evidence has shown that colorectal cancer screening can help save lives. Yet rates have long been low.

A previous Medscape Medical News story noted, "About 1 in 3 Americans aged 50 to 75 years, or 23 million people, have not been screened for colorectal cancer, as recommended by the US Preventive Services Task Force, according to new data released by the Centers for Disease Control and Prevention."

FDA approval for Plenvu was based on multiple phase 3 trials, including the NOCT study, which compared Plenvu with a trisulfate bowel cleansing solution using a 2-day split-dosing regimen in adults.

According to Salix, "Both primary endpoints were met, achieving noninferior 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."

Salix is a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. and its partner, Norgine BV. In Europe, the product is available through Norgine.

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