Weight Loss Drug Approval: FDA Confirms Use Of Prescription Drug For Weight Management

The U.S. Food and Drug Administration (FDA) has approved the prescription weight loss drug Plenity as an aid in weight management for adults with a BMI of 25 to 40. The drug is designed to be used with diet and exercise, according to its maker, Gelesis.

The new weight loss drug is the only prescription weight management product to be cleared by the FDA for use with overweight adults. According to Gelesis, it has no restriction on how long it can be taken to help with 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 chief executive officer of Gelesis said.

Patients that are prescribed Plenity will take the capsules with water before lunch and dinner. The drug works by “cross-linking two naturally derived building blocks – cellulose and citric acid – to create a three-dimensional hydrogel matrix.” This allows the particles in Plenity to absorb water in the stomach, creating volume and elasticity for a feeling of fullness, which can develop into weight loss.

According to Gelesis, Plenity is a non-stimulant drug that has been shown in clinical trials to be safe and well tolerated. Results from the clinical trials were recently published in the scientific journal "Obesity," which showed that 26 percent of the 436 adults,who participated in the trial, achieved at least a 10 percent or 30 pounds.

Gelesis said it plans to target the U.S. with the introduction of Plenity in the second half of 2019. The company expects the full release of the drug in the U.S. in 2020.