The FDA has cleared Gelesis100 hydrogel capsules to be used as a weight management aid alongside diet and exercise in adults with body mass indexes (BMIs) ranging from 25 to 40, according to an April 14 press release from the product’s manufacturer.
Marketed by biotechnology company Gelesis under the brand name Plenity, the prescription product is ingested orally and creates small gel pieces that expand in the stomach, making the user feel full. It is taken with water twice daily before lunch and dinner.
According to Gelesis, it’s the first prescription weight management tool to be cleared in individuals with BMIs as low as 25, even in the absence of comorbidities such as diabetes, hypertension or high cholesterol. There is also no restriction on how long Gelesis100 can be used for this purpose.
“Given the complexity of the disease of obesity and the need for expanded treatment options, the Obesity Action Coalition is encouraged to see continued innovation in safe and effective chronic weight management options,” Joe Nadglowski, president and CEO of the Obesity Action Coalition, said in the release. “We welcome Plenity’s addition as a treatment option for people affected by obesity.”
The FDA’s approval was supported by a double-blind, placebo-controlled trial of 436 adults with BMIs between 27 and 40 who received treatment for six months. Those taking Gelesis100 were twice as likely to achieve at least 5% weight loss and 59% of patients in the treatment group hit that mark.
Also, 26% of those given Gelesis100 were classified as “super-responders” in that they lost at least 10% of their body weight. These individuals lost 14% of their weight on average, or approximately 30 pounds. Adverse event rates were similar between study groups.
“The scientific data supporting Plenity’s positive effects on weight make it a powerful tool to help with weight management,” Ken Fujioka, MD, a weight loss expert and endocrinology researcher at Scripps Clinic and scientific advisor to Gelesis, said in the release.
“The most compelling aspects of this approach are its effectiveness, novel mechanism of action and impressive safety data. This approach creates another arm in the treatment algorithm of weight management and could be used by an overwhelming majority of people struggling with weight issues.”
Gelesis is planning a targeted U.S. launch for the second half of 2019 and nationwide availability of Gelesis100 in 2020, the release stated.