FDA OKs Suflave, a Lower-Volume Colonoscopy Prep Drink

The US Food and Drug Administration (FDA) has approved Suflave, a new low-volume, lemon-lime flavored liquid osmotic laxative for colonoscopy preparation in adults, the manufacturer, Sebela Pharmaceuticals, has announced.

Suflave comes in a carton containing two bottles and two flavor packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. One bottle and one flavor packet are equivalent to one dose.

Administration of both doses is required for a complete preparation for colonoscopy. After each dose, an additional 16 ounces of water must be consumed.

In a clinical trial, 94% of patients achieved successful bowel cleansing with Suflave, the company said in a news release.

Most patients reported that Suflave tastes like a sports drink and described the taste as "neutral to very pleasant." Most patients also reported that Suflave was "tolerable to very easy" to consume and indicated they would request it for a subsequent colonoscopy.

"Patients frequently struggle with the taste and volume of traditional bowel preparations — and fear related to the preparation can also negatively impact patient willingness to undergo follow-up colonoscopy if it is indicated," Douglas K. Rex, MD, gastroenterologist and distinguished professor emeritus at Indiana University School of Medicine, Indianapolis, said in the release.

"I believe the palatable lemon-lime flavor of Suflave will be a welcomed option for patients — reducing preparation hesitancy and giving more people the chance to feel comfortable during preparation and getting a successful and effective procedure," Rex added.

Suflave will be available by prescription to patients in the United States in early August.

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Lead image: Braintree/Sebela

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