FDA approves Suflave, Sebela’s low-volume, ‘lemon-lime’ flavored colonoscopy prep
Click Here to Manage Email Alerts
The FDA has approved Suflave, an osmotic laxative consisting of polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate and sodium chloride, for colonoscopy preparation in adults, according to the manufacturer.
Sebela Pharmaceuticals noted that patient tolerance for bowel preparation remains a significant deterrent for those considering screening colonoscopy, with most patients citing colonoscopy prep as the worst aspect “due to large volumes of poor-tasting solutions.” Intended to reduce prep hesitancy and improve patient compliance, the Suflave product offers a low-volume colonoscopy prep with “a taste similar to a lemon-lime” sports drink.
“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, Distinguished Professor Emeritus at Indiana University School of Medicine, 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.”
The company reported that, in a head-to-head study against its own oral sulfate product, Suprep bowel prep kit, Suflave demonstrated noninferiority with 94% of patients achieving successful bowel cleanse. Additionally, 79% of patients in the study reported that Suflave exhibited a “neutral to very pleasant” taste compared with Suprep. The majority of patients (87%) reported that they found Suflave “tolerable” or “very easy to consume,” with 80% of patients reporting that they would request Suflave in subsequent colonoscopies.
“We believe in patient choice and are committed to improving the colon preparation process for patients,” Alan Cooke, president and CEO of Sebela Pharmaceuticals, said in the release. “We are delighted with the FDA’s approval of Suflave — which has efficacy equivalent to Suprep, but with taste similar to a sports drink. We are proud of the hard work and dedication of the Braintree team and the phase 3 trials investigator group who continue to bring new, better choices to people undergoing colonoscopy screening.”
The most common adverse events reported for patients who received Suflave include abdominal pain and distension, headache, nausea and vomiting.
Perspective
Back to Top
Since colonoscopy is a lifesaving procedure, it is critical to find solutions for issues related to compliance.
Many patients describe drinking the bowel preparation before colonoscopy as more challenging than the procedure itself. Patients often ask about ways to handle the taste and volume of the prep, with many choosing prescribed preps with lemon, berry or other sports-drink flavor.
No one reported bowel prep to be “delicious.” A previous study concluded that about 70% of patients preferred citrus flavored polyethylene glycol (PEG) compared with unflavored PEG with ascorbate. Prep flavor was theorized in a previous study to be a possible cause of noncompliance.
The recently FDA approved lemon-lime flavored colonoscopy prep is a promising agent for bowel prep, with 79% of patients reporting “neutral to very pleasant” taste. The majority found it to be easy to consume and 80% stated they would request it in the future. In addition, it was not inferior to other bowel preps.
Further prospective studies are warranted to assess bowel prep with other flavors.
Reference:
Laiyemo AO, et al. World J Gastrointest Pharmacol Ther. 2015;doi:10.4292/wjgpt.v6.i3.84.
Read more about
Click Here to Manage Email Alerts