The FDA just cleared a new weight loss 'pill'—one with no side effects
Key Takeaways
Epitomee was recently granted FDA clearance for weight loss in people with a BMI of 25 and above.
While technically a medical device, the capsule is swallowed at home and promotes feelings of fullness and satiety—similar to GLP-1s but without the negative side effects.
Epitomee has a favorable safety profile and may appeal to more patients than other weight loss interventions.
While many patients are eager to begin taking weight loss drugs like Ozempic, barriers such as cost and concern over potential side effects can be significant roadblocks on the path to healthy weight maintenance.
Related: 'Ozempic personality' and the psychological toll of GLP-1sBut a new product has entered the scene. Epitomee, a capsule taken by mouth, was recently granted FDA clearance for patients with a BMI as low as 25.[] Unlike systemic drugs or invasive surgeries, Epitomee temporarily takes up space in the stomach to promote a sense of fullness. Within a few hours, the capsule passes through the digestive system.
It sounds like a simple answer to a difficult problem: How can we promote weight loss with an easy, at-home procedure without the risk of negative mental and physical side effects? It almost sounds too good to be true. Here’s what we know so far.
Here’s how it works
Once the Epitomee capsule is swallowed, pH levels in the stomach signal the capsule to open up to reveal a three-dimensional triangle that’s about 2.5 inches on each side.[] Operating mechanically, this structure is designed to absorb water and expand in the stomach, promoting satiety, thereby offering a temporary, chemical-free weight loss option.[] After several hours, Epitomee degrades and passes through the gastrointestinal tract naturally.[]
The RESET multicenter trial of Epitomee, on which the FDA clearance was based, included 279 overweight and obese adults.[] Some participants had prediabetes and others were non-diabetic. The trial was conducted at nine different sites throughout the US. Participants were randomized to take a placebo capsule or Epitomee twice daily for 24 weeks, along with a diet and exercise program.
The Epitomee groups achieved more significant weight loss than the placebo groups and reported a higher quality of life. Although the study design set a threshold of >35% for the co-primary endpoint (the rate of total body weight reduction of at least 5%), in the Epitomee treatment group, 55.5% of participants achieved this weight reduction, significantly exceeding the threshold.
No serious adverse effects were observed with Epitomee in the initial study or through an additional study that extended treatment to 48 weeks at three of the original sites.[] Overall, more participants dropped out of the control groups vs the Epitomee group, suggesting that Epitomee allowed for a safe and tolerable weight loss experience.
@luminoushealthnwellness #greenscreen Say hello to Epitomee, the new FDA-approved weight loss device! 🌟 It expands in your stomach, helping you feel full sooner and stay on track with your goals. Would you try it? #FDA #fdaapproved #Epitomee #WeightLoss #FeelFullFaster #obesity #weightloss #overweight #loseweight #obesitymedicine #obesitydoctor ♬ original sound - Dr. Medina
How it compares to older methods
The concept of mechanically filling the stomach for weight loss isn’t new. The non-surgical intragastric balloon Orbera was approved in 2015 to treat obesity.[] Although it’s minimally invasive, patients must be sedated for Orbera insertion via endoscopy. Once the deflated silicone balloon is placed in the stomach, the surgeon inserts a catheter to fill it with saline.
Orbera is meant to remain fully filled throughout the 6-month duration of the weight loss program.[] Patients are monitored for common side effects (like acid reflux) and coached on lifestyle tips for weight loss. Rare complications may include deflation and migration to block the intestines; perforation of the esophagus or stomach after placement, and spontaneous overinflation after placement, can also occur. After 6 months, patients must return to the office for sedation and removal of the balloon.
The cost of Orbera and other gastric balloons can range from $6,000 to $9,000, including anesthesia and hospital fees.[] Some insurers cover Orbera, but other patients need financing or loans to access the procedure. After the 6-month treatment period, gastric balloon patients are faced with deciding how to continue their weight loss journey: Can they go it alone, without assistance, or do they need to explore another maintenance drug or procedure?
Benefits… and challenges
Information about the cost of Epitomee isn’t available yet.
Some cost considerations compared to the gastric balloon include the fact that patients can swallow the Epitomee capsule themselves, and it dissolves independently after a short time. An endoscopy isn’t required for insertion or removal of the device, and neither is sedation.
The likelihood of insurance coverage for Epitomee remains to be seen. Capsules may need to be taken daily or multiple times per day, perhaps for a lifetime. However, given the FDA has cleared it for weight loss in patients without comorbidities at the lowest end of the overweight spectrum, there’s a good chance more people will have an opportunity to try it compared to other methods with tighter target populations.
What this means for you
Epitomee is an alternative weight loss tool that appeals to patients and providers who want to avoid surgery and injections. So far, there appears to be no red flags regarding safety. However, ultimately, cost and coverage will determine its accessibility in the real world.