TY - CHAP M1 - Book, Section TI - Obesity A1 - Sheehan, Amy Heck A1 - Chen, Judy T. A1 - Yanovski, Jack A. A1 - Calis, Karim Anton A2 - DiPiro, Joseph T. A2 - Talbert, Robert L. A2 - Yee, Gary C. A2 - Matzke, Gary R. A2 - Wells, Barbara G. A2 - Posey, L. Michael PY - 2017 T2 - Pharmacotherapy: A Pathophysiologic Approach, 10e AB - Content UpdateAugust 12, 2019Oral, Nonsystemic Hydrogel Approved for Weight Management in Adults: In April 2019, the U.S. Food and Drug Administration (FDA) approved a first-in-class oral, nonsystemic, superabsorbent hydrogel (Plenity) to aid in weight management in overweight and obese adults. The product is classified as a device (not a drug) and was shown to be safe and effective when used in combination with diet and exercise, resulting in significantly greater weight loss vs. placebo in patients with and without type 2 diabetes. The incidence of adverse events in the treatment group was no different from placebo. Plenity is the only prescription product to be approved for weight management in adults with a BMI as low as 25 kg/m2, and there is no restriction on its duration of use. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/04/16 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1164846292 ER -