| Clinical data | |
|---|---|
| Trade names | Rebyota |
| Other names | RBX2660, fecal microbiota, live - jslm |
| License data | |
| Routes of administration | Rectal |
| ATC code |
|
| Legal status | |
| Legal status | |
Fecal microbiota, sold under the brand name, Rebyota is used for the prevention of recurrence of Clostridioides difficile infection.[1][4]
The most commonly reported adverse reactions include abdominal pain, diarrhea, abdominal distention, flatulence, and nausea.[1]
Fecal microbiota is prepared from stool donated by qualified individuals.[4] The donors and the donated stool are tested for a panel of transmissible pathogens.[4] Fecal microbiota is the first fecal microbiota product approved by the US Food and Drug Administration (FDA).[4] Fecal microbiota was approved for medical use in the United States in November 2022.[4]
Medical uses
Fecal microbiota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in people 18 years of age and older.[4] It is for use after an individual has completed antibiotic treatment for recurrent CDI.[4]
History
The safety of fecal microbiota was assessed from two randomized, double-blind, placebo-controlled clinical studies and from open-label clinical studies conducted in the United States and in Canada.[4] The participants had a history of one or more recurrences of Clostridioides difficile infection.[4] They received one or more doses of fecal microbiota or placebo 24 to 72 hours after completion of antibiotic treatment for their Clostridioides difficile infection; participants' Clostridioides difficile infection was under control at the time of receipt of fecal microbiota or placebo.[4] Across these studies, 978 individuals aged 18 years and older received at least one dose of fecal microbiota.[4] In one study, among 180 fecal microbiota recipients, when compared to 87 placebo recipients, the most common side effects after receiving one dose of fecal microbiota were abdominal pain, diarrhea, abdominal bloating, gas and nausea.[4]
The FDA granted the application for fecal microbiota, live fast track, breakthrough therapy, and orphan drug designations.[4] The FDA granted approval of Rebyota to Ferring Pharmaceuticals Inc.[4]
Society and culture
Legal status
Fecal microbiota was approved for medical use in the United States in November 2022.[4][5]
References
- ^ a b c "Rebyota- donor human stool suspension". DailyMed. 13 January 2023. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
- ^ "Highlighting prescribing information". fda.gov. Archived from the original on 15 March 2023. Retrieved 4 April 2023.
- ^ "Rebyota". U.S. Food and Drug Administration (FDA). 30 November 2022. Archived from the original on 4 December 2022. Retrieved 4 December 2022.
- ^ a b c d e f g h i j k l m n o "FDA Approves First Fecal Microbiota Product". U.S. Food and Drug Administration (FDA). 30 November 2022. Archived from the original on 30 November 2022. Retrieved 1 December 2022.
This article incorporates text from this source, which is in the public domain.
- ^ "Ferring Receives U.S. FDA Approval for Rebyota (fecal microbiota, live-jslm) – A Novel First-in-Class Microbiota-Based Live Biotherapeutic". Ferring Pharmaceuticals USA. 1 December 2022. Archived from the original on 1 December 2022. Retrieved 1 December 2022.
Further reading
- Khanna S, Assi M, Lee C, Yoho D, Louie T, Knapple W, et al. (October 2022). "Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection". Drugs. 82 (15): 1527–1538. doi:10.1007/s40265-022-01797-x. PMC 9607700. PMID 36287379.
External links
- Clinical trial number NCT03244644 for "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)" at ClinicalTrials.gov
- Clinical trial number NCT02299570 for "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD2)" at ClinicalTrials.gov
- Clinical trial number NCT01925417 for "Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)" at ClinicalTrials.gov
- Clinical trial number NCT02589847 for "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection" at ClinicalTrials.gov
- Clinical trial number NCT03931941 for "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (CD3-OLS)" at ClinicalTrials.gov
This page was last edited on 15 January 2024, at 11:56