Gelesis100

Gelesis100
Other namesPlenity
Oral superabsorbent hydrogel

Gelesis100 (sold under the brand name Plenity) is an oral superabsorbent hydrogel used for weight loss in the treatment of obesity and overweight.[1] As Gelesis100 absorbs water, it expands in the stomach and small bowel. Gelesis100 is contraindicated in pregnancy, chronic malabsorption syndrome, and cholestasis.[1] Possible side effects include primarily gastrointestinal symptoms,[2] such as diarrhea, abdominal distension, infrequent bowel movements, constipation, abdominal pain and flatulence.[3] Approved in April 2019 by the US Food and Drug Administration 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]

Uses

Gelesis100 is used for weight loss in the treatment of obesity and overweight.[1] Gelesis100 is taken as a pill before meals[5] and with water.[6]

Mechanism and physiology

Gelesis100 is an oral superabsorbent hydrogel, which is produced from carboxymethylcellulose and citric acid.[1][7] The cross-linked product forms a hydrophilic matrix, which absorbs water.[1] As Gelesis100 absorbs water, it expands in the stomach and small intestine.[6][3] After absorbing water, a semisolid gel structure forms, which may promote satiety and result in weight loss.[1]

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 distension, infrequent bowel movements, constipation, abdominal pain and flatulence.[3] Gelesis100 is not associated with any severe adverse events.[8] However, long term safety data (beyond 24 weeks) is not available.[8]

References

  1. 1 2 3 4 5 6 7 Pass, A; Bialonczyk, D; Chiquette, E; Goldman, JD (2020-12-21). "Oral Superabsorbent Hydrogel (Plenity) for Weight Management". The Annals of Pharmacotherapy (9): 1060028020983046. doi:10.1177/1060028020983046. PMID 33348994.
  2. 1 2 3 Kahan, S; Kumbhari, V (February 2019). "A Weight Loss Device That Looks Like a Pill". Obesity (Silver Spring, Md.). 27 (2): 189. doi:10.1002/oby.22399. PMID 30677264. S2CID 59252036.
  3. 1 2 3 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. ↑ 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 (Silver Spring, Md.). 27 (2): 205–216. doi:10.1002/oby.22347. PMC 6587502. PMID 30421844.
  6. 1 2 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. ↑ 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.
  8. 1 2 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.
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