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In September 2024 the Food and Drug Administration (FDA) cleared a drug-free capsule for weight loss.[1] The capsule, which is marketed as Epitomee and classified as a medical device, contains a powder. When the capsule dissolves after it is swallowed, the powder absorbs water and expands to form a biodegradable, three-dimensional matrix designed to make the person who swallows it feel full and eat less. The capsule is classified as a medical device, not a drug, because it has a physical...
In September 2024 the Food and Drug Administration (FDA) cleared a drug-free capsule for weight loss.[1] The capsule, which is marketed as Epitomee and classified as a medical device, contains a powder. When the capsule dissolves after it is swallowed, the powder absorbs water and expands to form a biodegradable, three-dimensional matrix designed to make the person who swallows it feel full and eat less. The capsule is classified as a medical device, not a drug, because it has a physical means of action, not a pharmacologic effect.
Epitomee was cleared based on its “substantial equivalence” to a previous device that is also an oral absorbent hydrogel (Plenity). First cleared in 2019 for prescription use and costing about $100 for a four-week supply, Plenity became available over the counter in 2024.[2],[3],[4] Device clearance by the FDA is a lower standard than the one typically used for approving higher-risk devices, such as cardiac pacemakers, and new drugs.
Based on side-by-side comparisons, Plenity and Epitomee are nearly identical. Nonetheless, the manufacturer of Epitomee argues that their device is innovative because the stomach-filling matrix is a smaller volume than the one in Plenity, with a “triangular shape of the compartments…designed to attain relatively large dimensions.”[5]
Both oral capsules are for short-term (six-month) weight management in overweight and obese adults (body mass index [BMI] of 25-40 kilograms/meter2) and contain physiologically inert hydrogel particles (composed mostly of cellulose) that expand when released in the stomach and later pass through the gut without otherwise being absorbed or metabolized.[6] Both capsules are taken twice per day, just before meals.
Each device was evaluated in a separate randomized clinical trial. In addition to the use of the device or a placebo, both trials involved weight management with diet and exercise.
The Plenity trial involved 436 subjects who received daily doses of the product or a sham capsule filled with sugar. Mean participant age was 48 years, and 54% of the sample was classified as obese (BMI at least 30). Bottom-line efficacy results after 24 weeks of daily use were that the Plenity group lost an average of 6.4% of their body weight while the placebo group lost 4.4%, a significant but modest difference. Safety data revealed similar overall rates of adverse events but markedly more gastrointestinal symptoms (abdominal pain, diarrhea, or constipation and flatulence) in the Plenity group and more upper respiratory infections, arthralgia (joint pain) and headaches in the placebo group.
The Epitomee device was assessed in a similar randomized clinical trial with 279 subjects. The mean weight loss in each group was nearly identical to that with Plenity: 6.6% in the Epitomee group and 4.6% in the placebo group.[7] The safety profile of Epitomee was similar to Plenity’s profile.
Drug-free capsules for weight loss offer limited benefit, and many people who use them have substantial gastrointestinal symptoms. If you are considering such a device, discuss it with your clinician first.
References
[1] Food and Drug Administration. Clearance documents for: Ingested, transient, space occupying device for weight management and/or weight loss (Epitomee). September 13, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240544.pdf. Accessed November 25, 2024.
[2] Ibid.
[3] Food and Drug Administration. Clearance document for: Ingested, transient, space occupying device for weight management and/or weight loss (Plenity OTC). January 19, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230133.pdf. Accessed November 20, 2024.
[4] Food and Drug Administration. De novo classification request for Plenity. November 15, 2018. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180060.pdf. Accessed November 25, 2024.
[5] Food and Drug Administration. Clearance documents for: Ingested, transient, space occupying device for weight management and/or weight loss (Epitomee). September 13, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240544.pdf. Accessed November 25, 2024.
[6] Ibid.
[7] Ibid.
