Obese and obese people will soon have a new medical option to help them control their weight. On Monday, Gelesis, a biotechnology company from Boston, announced that it had been granted FDA authorization to sell its new weight loss aid, a plenity-based medical device that makes people feel more fully. fast
Fertility is unique in several respects, according to Harry Leider, medical director of Gelisey. Treatment is designed (along with diet and exercise) for people with a body mass index of up to 40. However, this is the first weight loss treatment approved by the FDA for people with a body mass index of up to 25, which is the threshold for someone who is considered overweight. Historically, this type of treatment is used only in people who are considered obese, with a BMI greater than 30. And its operation is also different from previous weight loss devices.
"What Plenity makes differently and uniquely, mainly, is in its mechanism of action, which uses superabsorbent hydrogel"Ladder told Gizmodo.
Hydrogen material is a patented blend of cellulose (a building block of plants that is commonly consumed as fiber) and citric acid formed in a three-dimensional matrix. This material, when introduced into water, can absorb up to 100 times the weight. When someone enters the scent with his food, according to the theory, it will expand into the stomach and small intestine, leaving less space available for food and will essentially convince your body to feel full before it would otherwise be.
"The body does not absorb it, so it works completely with mechanical action and safely leaves the body"Added Lader.
The FDA did not immediately respond to Gizmodo's request to comment on the drug.
The main evidence provided by FDA's Plenity approval is a randomized, double-blind, placebo-controlled study that included more than 400 ITM patients between 27 and 40. According to a trial published last November on the Internet, patients taking Plenitude for six months, along with diet and exercise, lost an average of 6.4 per cent of their starting weight, compared with an average of 4.4 per cent lost from those taking placebo.
It is a statistically significant difference, although modest, but Gelesis points to the success achieved, as according to the study, approximately 60 per cent of people who had taken Plleney lost at least 5 per cent of their body weight, while 27 per cent lost 10 per cent of body weight. By contrast, the chances of achieving any of the targets in the placebo group were approximately half, 42% and 15%, respectively. These successful responses became apparent very quickly because more than 85 percent who lost 5 percent or more of the body weight of the six-month mark lost 3 percent or more of body weight after the eight-week mark
"Obesity is probably not just one disease, but a lot. So almost no treatment will work for everyone"The leader said."But these reactionaries can be noticed soon"
Classified as a Class 2 medical device, Fertility will be felt as a typical remedy for people taking it. Consumers should take three capsules with a glass of water 20 to 30 minutes before lunch and dinner. Fruity will also be available only on prescription, although Gillysacks Operations Director David Pass told Gizmodo that he plans to create a telemedicine program where potential patients can be tested and copied with Plenity remotely, in addition to the available recipes in the office to your private doctor. The company may one day investigate the counter option, but not for the near future.
Plenity safety also seems to be impressive, as there was no significant difference in the amount and severity of the individual side effects reported compared to placebo. (In both groups, about 3 per cent reported serious side effects, although most occurred at the outset and lasted less than two weeks). However, mild gastrointestinal symptoms, such as abdominal pain or constipation, were more common in people who took Dementia.
"We did not try any of the greatest qualities [de Plenity], but from a scientific point of view, it should be relatively safe, even if it needs more"Leider answered when Gizmodo asked about the risks of someone accidentally taking more than three capsules."Only a few percent of the liquid can be absorbed at the same time"
However, treatment will not be recommended in pregnant women, people with severe digestive tract problems, such as Crohn's disease, and people with allergies to Plattit's ingredients, mainly citric acid and cellulose.
However, it will take some time before Plenity is widely available to the public. The company expects to test a limited release of the product by the end of 2019, with plans to be available nationally next year. Gelesis told Gizmodo that there is still no concrete price for Plenity, but added that the company is "dedicated to making Plenity available to most of our target customers, with or without insurance"
Gelesis also performs clinical trials to use the same, slightly modified hydrogel technology to help treat other conditions such as diabetes, soft fatty liver disease, and inflammatory bowel disease.