A weight loss aid that fills your stomach with less food has just been approved by the FDA

Overweight and obese people will soon have a new medical option to help them manage their weight. On Monday, Boston's biotech company, Gelesis, announced that it had received clearance from the Food and Drug Administration to market its new weight loss aid tool to the public. Tablets-based medical device called Plenity that allows patients to feel fuller faster.

Fullness is unique in many ways, according to Harry Leider, Gelesis Medical Director. The treatment is intended (with diet and exercise) for people with a body mass index as high as 40. But it's the first weight loss treatment approved or approved by the FDA for people with a body mass index as low as 25, which is the threshold for someone considered overweight. Historically, such treatments are only used by people considered obese, with a BMI greater than 30. And its functioning is also different from previous weight loss aids.

"What makes Plenity different and unique, is above all its mechanism of action, which uses a superabsorbent hydrogel," Leider told Gizmodo.

The hydrogel material is an exclusive blend of cellulose (the building block of plants, usually consumed as fiber) and citric acid formed into a three-dimensional matrix. This material, when introduced into the water, can absorb up to 100 times its weight. According to the theory, when someone eats Plenity with his meal, it expands in the stomach and in the small intestine, leaving less room for food and persuading your body to feel fully satiated sooner than he would otherwise.

"It is not absorbed by the body either, so it works entirely by its mechanical action and leaves the body safely," added Leider.

The FDA did not immediately respond to Gizmodo's request for comment.

The main piece of evidence that allowed the FDA to obtain Plenity's approval was a randomized, double-blind, placebo-controlled trial involving over 400 patients with a BMI between 27 and 40 According to the test published online last November, patients fullness for six months, combined with a diet and exercise program, lost an average of 6.4% of their body weight. base, compared to the average of 4.4% lost for placebo users.

This is a statistically significant difference, though modest, but Gelesis points out that the success achieved by so-called test responders is a better marker of Plenity's potential. According to the study, about 60% of people who took Plenity lost at least 5% of their weight, while 27% lost 10% or more. In contrast, the odds of achieving one or the other goal in the placebo group were about half as high, at 42% and 15%, respectively. These successes were generally apparent very quickly: over 85% of people who lost 5% or more of their body weight within six months had lost at least three percent of their body weight in eight weeks.

"Obesity is probably not a disease, but many. So, almost no treatment will work for everyone, "said Leider. "But these speakers can be noticed very early."

Classified as a Class 2 medical device, Plenity will nevertheless feel like a typical medicine for people who take it. Users will be asked to swallow three capsules with a glass of water 20 to 30 minutes before lunch and dinner. Plenity will also be available by prescription only, although Gelesis' Director of Operations, David Pass, told Gizmodo that he was considering a telemedicine program where potential patients could be screened and prescribed remotely. in addition to the prescriptions available from their doctor. The company may one day explore an over-the-counter option, but not for an immediate future.

The safety of Plenity also seems to be impressive, as there was no significant difference in the amount and severity of individual side effects reported compared to placebo. (In both groups, about 3% reported serious adverse events, although most occurred early and lasted less than two weeks.) However, mild gastrointestinal symptoms, such as stomach or constipation, were more common overall in people taking Plenity.

"We have not tested larger qualities [of Plenity]but from a scientific point of view, it should be relatively safe, even if you take more, "Leider replied when Gizmodo asked about the risks of accidentally taking more than three capsules. "There is only one amount of liquid that can be absorbed at a time."

That said, the treatment will not be recommended for pregnant women, people with serious digestive problems, such as Crohn's disease, and those allergic to Plenity's ingredients, mainly citric acid and cellulose.

However, it will take some time before Plenity is widely available to the public. The company plans to test and launch a limited product before the end of 2019, and make it available throughout the country during the next year. Gelesis' Pass told Gizmodo that there was still no concrete list price for Plenity, but added that the company "is committed to making Plenity affordable for the majority of our target customers, with or without insurance."

Gelesis is also continuing its clinical trial efforts to use the same, slightly modified hydrogel technology to treat other conditions such as diabetes, non-alcoholic fatty liver disease and inflammatory bowel disease.