FDA clears Gelesis weight-loss hydrogel pill Plenity

 

[Image from Gelesis]

Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug.

 

The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management.

“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” Yishai Zohar, founder and CEO of Gelesis, said in a press release. “With Plenity, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies.”

Plenity is taken in the form of capsules with water before lunch and dinner. It is made by cross-linking cellulose and citric acid to make a 3D hydrogel matrix. When taken, the capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach to create small gel pieces that have the elasticity of plant-based foods with no calories. The gel pieces help by increasing the volume and elasticity of the stomach and small intestine, helping the body feel more full to induce weight loss.

“More than 150 million Americans struggle with excess or unhealthy weight. Unfortunately, the majority of individuals with weight issues have important weight-related medical problems. There is no doubt that making a significant impact on this issue should be America’s number one public health priority,” said Dr. Ken Fujioka, a weight loss expert and endocrinology researcher at Scripps Clinic and scientific advisor to Genesis. “The scientific data supporting PLENITY’s positive effects on weight make it a powerful tool to help with weight management. 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.”

The drug, which is a non-stimulant and non-systemic treatment for obesity, has been shown in clinical studies as being effective, safe and well-tolerated. The studies showed that Plenity had a combination of effectiveness and highly favorable safety and tolerability profile.

“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. We welcome Plenity’s addition as a treatment option for people affected by obesity,” Joe Nadglowski, president and CEO of the Obesity Action Coalition.

from MassDevice http://bit.ly/2P8ded6