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The FDA has authorized Gelesis100 (Fullness, Gelesis) for weight management in adults with a body mbad index (BMI) of 25 – 40 kg / m2, when used with diet and exercise, according to a press release.
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 over and obesity if it is defined at 30 kg / m2 and over.
"More than 150 million Americans are overweight or unhealthy. Unfortunately, the majority of people with weight problems have significant weight-related medical problems. There is no doubt that the US's top public health priority is expected to have a significant impact on this issue, "Dr. Ken Fujioka, a weight loss expert, researcher in endocrinology at the University of California, said in a statement. Scripps Clinic and Scientific Advisor Gelesis.
"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 treatment 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 co-primary endpoints of the study were 35% or more of Plenity patients who lost at least 5% (weight loss) and placebo-adjusted weight loss with a margin of superiority. of 3%. The researchers also performed a predefined badysis of simple superiority.
The test "met and exceeded the predefined categorical badessment criterion"; 59% of people in the treatment group lost at least 5% of their weight.
Gelesis 100 demonstrated a superiority over placebo (-6.4% vs. -4.4%, P = 0.0007) but did not achieve the super-superiority criterion of 3%. People who received Gelesis 100 were twice as likely to lose at least 5% of their weight compared to placebo (adjusted odds ratio, 2.0; P = 0.0008).
More than a quarter (26%) of those who completed the study were "super-responders" to Gelesis 100, which the researchers defined as having suffered 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 Gélèse 100 group versus 28% in the placebo group), infections and infestations (1% in each of the Gélèse 100 and placebo groups), as well as tissue disorders (1% in the Gélèse group and 0% in the placebo group).
No serious adverse events occurred in the Gélèse 100 group and one in the placebo group.
The company plans to launch the product in the second half of 2019.
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