FDA Approves New Weight Management Option

The FDA has approved Plenity (gelesis100), a new nonstimulant, non-systemic prescription weight management aid for the treatment of adults with body mass index (BMI) of 25-40 kg/m2, used in conjunction with diet and exercise.

Plenity is an oral hydrogel capsule made from cellulose and citric acid that releases thousands of calorie-free particles with the elasticity of plant-based foods that increase the volume and elasticity of the stomach, contributing to a feeling of fullness.

Read More...
Time-Restricted Eating May Improve BP, Weight Loss in Metabolic Syndrome
Diabetes Remission Possible With Primary Care Weight Loss Program

The safety and effectiveness of the option were examined in 5 clinical studies in which it was shown to induce weight loss through increased satiety and reduced hunger when combined with diet and exercise.

In a recent multicenter, double-blind, placebo-controlled pivotal study involving 436 adults with overweight or obesity (BMI ≥ 27 and ≤ 40 kg/m2), 59% of adults in the treatment group achieved weight loss of 5% or greater and those treated with Plenity had a greater chance of achieving at least 5% weight loss vs placebo (adjusted odds ratio 2.0).

The most common treatment related adverse events included gastrointestinal disorders, infections and infestations, and musculoskeletal and connective tissue disorders.

—Michael Potts

Reference:

Gelesis Granted FDA Clearance to Market PLENITY™ — a New Prescription Aid in Weight Management [press release]. Boston, Massachusetts. April 14, 2019. https://www.gelesis.com/2019/04/14/gelesis-granted-fda-clearance-to-market-plenitytm-a-new-prescription-aid-to-weight-management/.