Gelesis100

Gelesis100
Other namesPlenity
Oral superabsorbent hydrogel

Gelesis100, sold under the brand name Plenity, is an oral hydrogel used to treat overweight and obesity.[1] It absorbs water and expands in the stomach and small bowel thereby increasing feelings of fullness. Possible side effects include primarily gastrointestinal symptoms,[2] such as diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence.[3] It is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis.[1] The US Food and Drug Administration approved it in 2019 as a medical device. Gelesis100 was developed by the company Gelesis.

History

The US Food and Drug Administration approved the use of Gelesis100 in April 2019 as a medical device.[4] Gelesis100 is the first treatment of its kind for overweight and obesity.[2] In 2022, the American Gastroenterology Association published a guideline for the management of obesity, which recommended the use of Gelesis100 be limited to clinical trials due to limited evidence.[5]

Uses and effectiveness

Gelesis100 is used to treat obesity and overweight as an anti-obesity medication.[1] Gelesis100 is taken as a pill before meals with water.[6][7]

Gelesis100 has been criticized for its small impact on weight loss relative to side effects.[8]

Mechanism and physiology

Gelesis100 is an oral superabsorbent hydrogel, which is produced from carboxymethylcellulose and citric acid.[1][9] The cross-linked product forms a hydrophilic matrix, which absorbs water.[1] Taken in capsule form by mouth,[10] as Gelesis100 absorbs water, it expands in the stomach and small intestine.[3][6] After absorbing water, a semisolid gel structure forms, which may promote satiety and result in weight loss[1] via reduced caloric intake.[5]

Contraindications

Gelesis100 is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis.[1]

Side effects

Side effects consist of minor gastrointestinal symptoms,[2] including diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence.[3] Gelesis100 is not associated with any severe adverse events.[11] However, long-term safety data beyond 24 weeks is not available.[11]

References

  1. ^ a b c d e f g Pass, A; Bialonczyk, D; Chiquette, E; Goldman, JD (2020-12-21). "Oral Superabsorbent Hydrogel (Plenity) for Weight Management". The Annals of Pharmacotherapy. 55 (9): 1146–1152. doi:10.1177/1060028020983046. PMID 33348994. S2CID 229351539.
  2. ^ a b c Kahan, S; Kumbhari, V (February 2019). "A Weight Loss Device That Looks Like a Pill". Obesity. 27 (2): 189. doi:10.1002/oby.22399. PMID 30677264. S2CID 59252036.
  3. ^ a b c Lee, Bruce Y. (Apr 18, 2019). "Plenity Now Is FDA-Approved For Weight Management". Forbes.
  4. ^ "De Novo request for classification of Plenity" (PDF). U.S. Food & Drug Administration.
  5. ^ a b Grunvald, E; Shah, R; Hernaez, R; Chandar, AK; Pickett-Blakely, O; Teigen, LM; Harindhanavudhi, T; Sultan, S; Singh, S; Davitkov, P; AGA Clinical Guidelines, Committee (November 2022). "AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity". Gastroenterology. 163 (5): 1198–1225. doi:10.1053/j.gastro.2022.08.045. PMID 36273831.
  6. ^ a b Umashanker, D; Igel, LI; Kumar, RB; Aronne, LJ (April 2017). "Current and Future Medical Treatment of Obesity". Gastrointestinal Endoscopy Clinics of North America. 27 (2): 181–190. doi:10.1016/j.giec.2016.12.008. PMID 28292399.
  7. ^ Greenway, FL; Aronne, LJ; Raben, A; Astrup, A; Apovian, CM; Hill, JO; Kaplan, LM; Fujioka, K; Matejkova, E; Svacina, S; Luzi, L; Gnessi, L; Navas-Carretero, S; Alfredo Martinez, J; Still, CD; Sannino, A; Saponaro, C; Demitri, C; Urban, LE; Leider, H; Chiquette, E; Ron, ES; Zohar, Y; Heshmati, HM (February 2019). "A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss". Obesity. 27 (2): 205–216. doi:10.1002/oby.22347. PMC 6587502. PMID 30421844.
  8. ^ Miller, LE; Bhattacharyya, R (September 2019). "Unclear Benefit of Gelesis100 for Body Weight Loss". Obesity. 27 (9): 1383. doi:10.1002/oby.22532. PMID 31264776. S2CID 195771241.
  9. ^ Naguy, A; Alamiri, B (March 2020). "2019 FDA approved psychotherapeutic medications". Asian Journal of Psychiatry. 49: 101976. doi:10.1016/j.ajp.2020.101976. PMID 32120296. S2CID 211831891.
  10. ^ Appleby, Julie (June 22, 2022). "New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results". Kaiser Health News.
  11. ^ a b Mechanick, JI; Apovian, C; Brethauer, S; Garvey, WT; Joffe, AM; Kim, J; Kushner, RF; Lindquist, R; Pessah-Pollack, R; Seger, J; Urman, RD; Adams, S; Cleek, JB; Correa, R; Figaro, MK; Flanders, K; Grams, J; Hurley, DL; Kothari, S; Seger, MV; Still, CD (December 2019). "Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures – 2019 Update". Endocrine Practice. 25 (12): 1346–1359. doi:10.4158/GL-2019-0406. PMID 31682518.