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The United States Food and Drug Administration (FDA) has authorized Gelesis100 (Fullness, Gelesis) for weight management in adults with a body mass index (BMI) of 25 – 40 kg / m2when used with a diet and exercises, according to a press release from the company.
The prescription device is a capsule containing hydrogel particles that dilate in the stomach after ingestion but are not absorbed systemically, allowing the user to feel full. They are taken twice a day with water before meals.
The definition of overweight is a BMI of 25 kg / m2 and more, and obesity is set at 30 kg / m2 and more.
"More than 150 million Americans are struggling with being overweight or unhealthy.Unfortunately, the majority of people with weight problems have significant weight-related health problems." no doubt the major impact on this issue should be the number one priority in public health in America "Ken Fujioka, MD, Weight Loss Expert and Endocrinology Researcher at Scripps Clinic and Scientific Advisor to Gelesis, said in a press release.
"The scientific evidence supporting the positive effects of Plenity on weight make it a powerful tool for weight management, and the most compelling aspects of this approach are its effectiveness, its new mechanism of action and its This approach creates another arm in the weight management algorithm and could be used by an overwhelming majority of people struggling with weight issues, "Fujioka said.
The FDA decision follows the inclusion of data from a multi-center, double-blind, placebo-controlled pivotal trial that evaluated weight variation in 436 overweight or obese adult patients (BMI ≥ 27 and ≤ 40 kg / m2) after 6 months of treatment.
The two predefined evaluation criteria of the study were 35% or more of the percentage of patients in the Plenity group having lost at least 5% (categorical weight loss) and a placebo-adjusted weight loss with a margin Superiority superiority of 3%. The researchers also performed a predefined analysis of simple superiority.
The test "met and exceeded the predefined categorical assessment criterion", with 59% of people in the treatment group having lost at least 5% of their weight.
Gelesis100 demonstrated superiority over placebo (-6.4% vs. -4.4%; P = 0.0007) but did not achieve the super-superiority criterion of 3%. People who received Gelesis100 were twice as likely to lose at least 5% weight compared to placebo (adjusted odds ratio, 2.0; P = 0.0008).
More than a quarter (26%) of those completing the study were "super-responders" to Gelesis100, which the researchers defined as having experienced a weight loss of at least 10%. Participants in this group lost an average of 15% or about 30 pounds.
Adverse events were similar in the treatment and placebo groups. The most commonly observed treatment-related adverse events were gastrointestinal disorders (38% in the Gelesis100 group and 28% in the placebo group), infections and infestations (1% in each of the Gelesis100 and placebo groups), and as musculoskeletal disorders and connective tissue. (1% in the Gelesis100 group and 0% in the placebo group).
No serious adverse events occurred in the Gelesis100 group and one in the placebo group.
The company plans to launch the product in the second half of 2019.
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