The US Food and Drug Administration (FDA) has given its approval to Suflave, a colonoscopy preparation product developed by Braintree Laboratories, a division of Sebela Pharmaceuticals.

Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate and sodium chloride for oral solution) is an osmotic laxative intended for colon cleansing in adults prior to a colonoscopy. It is noteworthy for its lemon-lime flavor, which likens it to a sports drink.

“We believe in Patient choice and are committed to improving the colon preparation process for patients. We are delighted with the FDA’s approval of Suflave — which has efficacy equivalent to Suprep, but with a taste similar to a sports drink,” said Alan Cooke, president and CEO of Sebela Pharmaceuticals, in the company’s news release. “We are proud of the hard work and dedication of the Braintree team and the Phase III trials investigator group who continue to bring new, better choices to people undergoing colonoscopy screening.”

Sabela Pharmaceuticals is a US-based company with headquarters in Roswell, Georgia, and additional locations in Boston, Massachusetts and Dublin, Ireland.

XTALKS WEBINAR: Intelligent Drug Development: A New Service Paradigm for Small Pharma

Live and On-Demand: Thursday, July 27, 2023, at 10am EDT (4pm CEST/EU-Central)

Register for this free webinar to discover a new paradigm, intelligent drug development, designed to support small pharma in efficiently navigating early clinical development.

How Can Suflave Boost Patient Compliance?

A colonoscopy, a procedure involving the visual examination of the colon using a scope, is one of the most common screening methods for colorectal cancer, the third most prevalent cancer globally. Nearly all international and national gastroenterology and cancer societies endorse this procedure as an initial screening tool or a follow-up measure after a positive fecal occult blood test. It is generally recommended for individuals at average risk, to be performed every ten years starting at the age of 50.

The effectiveness of the colonoscopy is significantly influenced by the quality of bowel preparation, which can be achieved using enemas or specialized drinks known as bowel preps or colonoscopy preparations. There are primarily two types of these preparations: those based on polyethylene glycol (PEG) and those based on saline. While PEG-based formulas are widely used due to their effectiveness and safety, they traditionally necessitate a large-volume preparation of up to 4 liters. Despite their efficacy, the unpleasant taste and substantial volume of liquid intake required by these preparations often deter patients from adhering to them.

With the introduction of Suflave, a low-volume, lemon-lime-flavored colonoscopy preparation, Sabela Pharmaceuticals aims to overcome these hurdles and boost patient compliance.

Clinical Trials Behind the FDA Approval

In two randomized, single-blind, active-controlled, multicenter clinical trials (Study 1 and Study 2), Suflave was evaluated against Suprep Bowel Prep Kit, an FDA-approved saline-based comparator. The trials sought to assess Suflave’s cleansing efficacy and safety in adult patients undergoing colonoscopies for colorectal cancer screening and surveillance, or diagnostic colonoscopies, including patients with abdominal pain, diarrhea, constipation and non-severe inflammatory bowel disease.

Study 1 revealed that Suflave achieved a 93 percent cleansing success rate, compared to 89 percent for Suprep, while Study 2 reported equivalent success rates of 94 percent for both Suflave and the comparator. The most commonly reported adverse reactions (≥ 2 percent) to Suflave were nausea, abdominal distension, vomiting, abdominal pain and headache.

Overall, Suflave was well-tolerated by most patients, many of whom reported that it tasted like a sports drink, with its flavor ranging from neutral to pleasant. Around eight in ten patients indicated that they would request Suflave for their next colonoscopy.

How to Take Suflave?

A complete bowel preparation for colonoscopy consists of two doses of Suflave in a split-dose (two-day) regimen:

• First dose: On the evening before the colonoscopy, the patient is to consume one bottle of water mixed with the flavor-enhancing packet.
• Second dose: On the morning of the colonoscopy, the patient is to take the second bottle of water mixed with another flavor-enhancing packet. This should be done five to eight hours before the procedure and not earlier than four hours after starting the first dose.

Each dose includes one packet of electrolytes and one flavor enhancer packet. Patients are also advised to drink an additional 16 ounces of water after each dose.

Suflave is contraindicated for individuals with a gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention or hypersensitivity to any of its ingredients.

Sabela Pharmaceuticals says the product will be available by prescription starting in August.

In addition to Suflave, Braintree Laboratories’ product portfolio includes Sutab, a tablet preparation for a colonoscopy that received FDA approval in November 2020.