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Rebyota™ (fecal microbiota, live – jslm) has been made available in the US to prevent recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following antibiotic treatment for recurrent CDI.
Rebyota is a fecal microbiota suspension for rectal administration. The product is manufactured from human fecal matter sourced from qualified donors and is tested for transmissible pathogens.
The approval was based on data from the pivotal phase 3 PUNCH CD3 (ClinicalTrials.gov Identifier: NCT03244644) and phase 2 PUNCH CD2 (ClinicalTrials.gov Identifier: NCT02299570) trials. Findings from the trials showed a significantly higher rate of treatment success (defined as the absence of CDI diarrhea) at 8 weeks with Rebyota compared with placebo.
The most common adverse reactions reported included abdominal pain/distention, diarrhea, flatulence, and nausea. As the product is manufactured from human fecal matter, there is a risk it may carry infectious agents or food allergens.
Rebyota is supplied as a rectal suspension; a single dose is 150mL. The product is administered rectally 24 to 72 after the last dose of antibiotics for CDI.
Ferring has established the Rebyota Connect Program to help patients access the treatment. Health care providers can enroll their patients by visiting rebyotaconnect.com.
References
- Ferring Pharmaceuticals announces availability of Rebyota™ (fecal microbiota, live – jslm) – the first and only fda-approved microbiome-based treatment for the prevention of recurrence of C. diff infection in adults. News release. Ferring Pharmaceuticals. Accessed February 14, 2023. https://www.businesswire.com/news/home/20230214005018/en/Ferring-Pharmaceuticals-Announces-Availability-of-REBYOTA%E2%84%A2-fecal-microbiota-live-%E2%80%93-jslm-%E2%80%93-the-First-and-Only-FDA-Approved-Microbiome-Based-Treatment-for-the-Prevention-of-Recurrence-of-C.-diff-Infection-in-Adults.
- Rebyota. Package insert. Ferring Pharmaceuticals; 2023. Accessed February 14, 2023. https://ferringus2.corporate-us.ferring.tech/wp-content/uploads/sites/12/2022/12/9009000002_REBYOTA-PI_11-2022.pdf.
