FDA OKs Prescription Weight Management Therapy – APhA submits compounding comments to FDA. – (866) 348-2889.
Officials with the US Food and Drug Administration have approved a therapy, Plenity, by PureTech Health affiliate Gelesis, which is designed to provide weight management assistance to overweight adults.
To be used in conjunction with diet and exercise, Plenity is an orally-administered capsule containing a nonstimulant, nonsystemic, superabsorbent hydrogel that is designed to absorb water and increase the volume and elasticity of the stomach and small intestine contents to help people feel full. It is the only prescription weight management product to be cleared for use by overweight adults with a BMI as low as 25 kg/m2, with or without comorbidities such as hypertension, type 2 diabetes or dyslipidaemia.