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MEDTECH The product is expected to be available in early August.
The FDA has given its approval to Suflave™, an osmotic laxative designed for colon cleansing prior to colonoscopy in adults. This marks a significant step in providing a low-volume preparation method with taste likened to a sports drink. The approval was rooted in robust clinical trials, focusing on efficacy and safety, leading to a promising alternative in colonoscopy preparation.
Key Points:
- Suflave, containing polyethylene glycol 3350 and various electrolytes, has been approved by the FDA as a colonoscopy preparation for adults.
- Two randomized, single-blind, active-controlled trials (Study 1 and Study 2) were the basis of the approval, with ClinicalTrials.gov Identifiers NCT04446299 and NCT04446312.
- 93% (Study 1) and 94% (Study 2) of patients receiving Suflave achieved successful bowel preparation, as rated by blinded endoscopists, compared with 89% and 94% for active comparators.
Additional Points:
- Suflave will be supplied in cartons containing 2 bottles and 2 lemon-lime flavor enhancing packets.
Conclusion:
- Suflave’s approval, reflecting a strong performance in clinical trials, brings a new, efficient option for colonoscopy preparation that emphasizes patient choice and improves the taste experience.
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“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 taste similar to a sports drink.”
Alan Cooke
President and CEO
Sebela Pharmaceuticals
