The FDA has granted clearance for the Epitomee® capsule, a self-administered device designed to aid weight management in adults with a body mass index (BMI) of 25 to 40 kg/m², when used alongside lifestyle modifications. Once swallowed, the Epitomee capsule expands in the stomach, creating a sensation of fullness, and then moves to the intestines, where it disintegrates and is naturally excreted.
The FDA’s decision was supported by data from the RESET trial (NCT04222322), a randomized, double-blind, placebo-controlled study of 279 overweight and obese adults, some of whom had prediabetes. Participants were assigned to take the Epitomee capsule or a placebo twice daily in addition to diet and exercise. Results showed that Epitomee users had significantly greater weight loss compared to those in the placebo group (P <.0001). Furthermore, 55.5% (95% CI, 46.1-64.6) of the Epitomee group achieved a weight loss of at least 5% of baseline weight over 24 weeks.
As reported by empr, long-term safety was confirmed in the ELECT trial (NCT04994769), a 48-week, open-label study with patients who had successfully completed the initial 24-week period and lost at least 3% of their baseline weight. Results indicated a favorable safety profile for extended use.
“Our capsule offers a safe, effective, and drug-free approach for those struggling with weight management,” said Dan Hashimshony, PhD, CEO of Epitomee Medical Ltd. “We are excited to bring this innovative product to the US market and look forward to strategic partnerships to maximize its potential.”