In a rare move, the Food and Drug Administration (FDA) has approved a novel prescription device meant to help with weight loss management.
The product, called Plenity and developed by Gelesis, has been cleared for overweight or obese adults with a body mass index of at least 25, even if they do not have other health problems. FDA warns it still needs to be used in conjunction with diet and exercise.
That sweeping approval is noteworthy, according to Dr. Caroline Apovian, who has studied Plenity in Gelesis-sponsored research and is the director of nutrition and weight management at Boston Medical Center. Most weight-loss treatments are available only to patients with a BMI of 30 or above, or who have other weight-related health issues and hyperlipidemia, pre or diabetes, heart disease, among other issues. For those who are overweight or have a BMI of 25 and 30 there’s a big treatment gap. If you’re overweight and you have no other issues, all healthcare providers have to offer are suggestions on how to improve lifestyle. Now, there is a treatment to be used in conjunction with those healthy changes.
It has traditionally been difficult to find science-backed, non-surgical weight-loss aids that work. The FDA has approved only five prescription weight-loss medicines. But these are for those with a BMI of greater than 30 and they all have their own issues. The FDA has repeatedly warned consumers against taking products claiming they can cause weight-loss “miracles.” Over-the-counter dietary supplements promising weight loss, which are not regulated by the FDA, also tend to be ineffective at best, and unsafe or tainted at worst (see post). Even some FDA-approved weight-loss drugs have been pulled from the market because of safety issues.
Previously approved weight-loss medicines typically work by targeting the brain to suppress appetite or simulate feelings of fullness. Plenity, by contrast, helps fill the stomach when taken before a meal. Each pill contains a mix of cellulose and citric acid, which, when hydrated in the stomach, expands to form a hydrogel with the consistency of chewed food. The capsules can fill about a quarter of the stomach without contributing any calories, helping people feel full from eating less, according to the company. The gel then passes through the digestive system just like regular food.
“It creates a sense of satiety, but it’s not a compound that enters the bloodstream and goes to the brain,” Apovian says. “In that respect, it’s so unique because it’s actually benign and safe, in terms of side effects that can cause issues centrally. It’s a very safe, low-risk alternative.”
Gelesis, the manufacturer, says the device has been shown to help people lose an average of 10% of their body weight in six months. In one study they sponsored published in the journal Obesity last fall, researchers including Dr. Apovian found that people taking Plenity had twice the odds of losing 5% or 10% of their body weight over six months, compared to people taking a placebo. Plenity seemed to be particularly effective for people with elevated fasting blood glucose levels and prediabetes, according to the study.
The most common side effects reported in the Obesity study were gastrointestinal symptoms. The device should not be used by pregnant women, people who are allergic to the device’s contents, those with esophageal abnormalities or strictures or individuals with complications from previous gastrointestinal tract surgeries. People with active gastrointestinal issues and those taking certain prescription drugs should also use caution, the company says.
PLENITY is administered in the form of capsules taken with water before lunch and dinner. PLENITY is made by cross-linking two naturally-derived building blocks – cellulose and citric acid – to create a three-dimensional hydrogel matrix. The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity (firmness) of plant-based foods (e.g., vegetables) without caloric value. The gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss. This novel, non-stimulant and non-systemic treatment has been shown in clinical studies to be effective, safe and well-tolerated.
Gelesis plans to initiate a targeted U.S. launch of PLENITY in the second half of 2019 and anticipates PLENITY will be broadly available by prescription in the U.S. in 2020.
More than 150 million Americans struggle with excess or unhealthy weight. And the majority of individuals with weight issues have important weight-related medical problems as well. There is no doubt that making a significant impact on this issue should be America’s number one public health priority. If this can help, along with emphasizing long term healthy lifestyle changes that include physical activity and a better diet, I look forward to seeing more information.
It has traditionally been difficult to find science-backed, non-surgical weight-loss aids that work. Until PLENITY, (see last weeks post) the FDA had approved only five prescription weight-loss drug. But they are for those with a BMI greater than 30. When combined with changes to behavior, including a healthier diet and increasing physical activity habits, prescription medications may help some people lose weight. Unfortunately, you will probably regain some of the lost weight after you stop taking them, but developing and maintaining healthy eating habits and increased physical activity may help you regain less weight or keep it off. See the new Federal physical activity guidelines (??? Link) that recommends at least 150 minutes a week of moderate-intensity aerobic activity and at least 2 days a week of muscle-strengthening activities. You may need to do more than 300 minutes of moderate-intensity activity a week to reach or maintain your weight-loss goals.
Prescription medications to treat obesity work in different ways. For example, some medications may help you feel less hungry or full sooner. Other medications may make it harder for your body to absorb fat from the foods you eat. On average, people who take prescription medications as part of a lifestyle program lose between 3 and 9 percent more of their starting body weight than people in a lifestyle program who do not take medication. Results vary by medication and by person.
5 to 10 percent weight loss of your starting body weight may not sound like much but it can help improve your health by lowering blood sugar, blood pressure, and triglycerides. Losing weight can also improve some other health problems related to being overweight and obesity, such as joint pain or sleep apnea. Most weight loss takes place within the first 6 months of starting the medication.
The table below lists FDA-approved prescription medications for weight loss. The FDA has approved five of these drugs—orlistat (Xenical, Alli), lorcaserin (Belviq), phentermine-topiramate (Qsymia), naltrexone-bupropion (Contrave), and liraglutide (Saxenda)—for long-term use. You can keep taking these drugs as long as you continue to document benefit from treatment and no side-effects.
Prescription Medications Approved for Overweight and Obesity Treatment (source: niddk.nih.gov/)
|Weight-loss medication||Approved for||How it works||Common side effects||Warnings|
Available in lower dose without prescription (Alli)
|Adults and children ages 12 and older||Works in your gut to reduce the amount of fat your body absorbs from the food you eat||
||Rare cases of severe liver injury have been reported. Avoid taking with cyclosporine . Take a multivitamin pill daily to make sure you get enough of certain vitamins that your body may not absorb from the food you eat.|
|Lorcaserin (Belviq)||Adults||Acts on the serotonin receptors in your brain. May help you feel full after eating smaller amounts of food.||
||Tell your doctor if you take antidepressants or migraine medications, since some of these can cause problems when taken together.|
||Adults||A mix of two medications: phentermine, which lessens your appetite, and topiramate, which is used to treat seizures or migraine headaches. May make you less hungry or feel full sooner.||
||Don’t use if you have glaucoma or hyperthyroidi
MAY LEAD TO BIRTH DEFECTS. DO NOT TAKE QSYMIA IF YOU ARE PREGNANT OR PLANNING A PREGNANCY. Do not take if you are breastfeeding.
||Adults||A mix of two medications: naltrexone, which is used to treat alcohol and drug dependence, and bupropion, which is used to treat depression or help people quit smoking. May make you feel less hungry or full sooner.||
||Do not use if you have uncontrolled high blood pressure, seizures or a history of anorexia or bulimia nervosa . Do not use if you are dependent on opioid pain medications or withdrawing from drugs or alcohol. Do not use if you are taking bupropion (Wellbutrin, Zyban).
MAY INCREASE SUICIDAL THOUGHTS OR ACTIONS.
Available by injection only
|Adults||May make you feel less hungry or full sooner. At a lower dose under a different name, Victoza, FDA-approved to treat type 2 diabetes.||
||May increase the chance of developing pancreatitis. Has been found to cause a rare type of thyroid tumor in animals.|
|Other medications that curb your desire to eat include
||Adults||Increase chemicals in your brain to make you feel you are not hungry or that you are full.
Note: FDA-approved only for short-term use—up to 12 weeks
||Do not use if you have heart disease, uncontrolled high blood pressure, hyperthyroidism, or glaucoma. Tell your doctor if you have severe anxiety or other mental health problems.|
Some weight-loss medications that curb appetite have only been approved by the FDA for short-term use, or up to 12 weeks. Although some doctors prescribe them for longer periods of time, not many research studies have looked at how safe and effective they are for long-term use.
Pregnant women should never take weight-loss medications. Women who are planning to get pregnant should also avoid these medications, as some of them may harm a fetus.
Pills are never the only answer but in some appropriate cases they may ” jump start” or help to change entrenched behaviors and habits moving those in need to a healthier lifestyle.