RBX2660 (REBYOTA^®) in preventing recurrence of Clostridioides difficile infection: a profile of its use in the USA

RBX2660 (fecal microbiota, live-jslm; REBYOTA^®) is an emerging option for the prevention of recurrent Clostridioides difficile infection (CDI) following standard of care (SOC) antibiotics. RBX2660 is a first-in-class, live biotherapeutic product available as a single-dose microbiota suspension for rectal administration. RBX2660 was effective in reducing recurrent CDI following SOC antibiotic therapy in the pivotal, phase 3 PUNCH CD3 trial. In a Bayesian analysis model, RBX2660 was superior to placebo in terms of treatment success, defined as the absence of CDI diarrhea within 8 weeks of study treatment. Most patients with treatment success at 8 weeks remained free of CDI recurrence at 6 months. The effectiveness of RBX2660 has also been demonstrated in the real-world setting. RBX2660 was well tolerated in the PUNCH CD3 trial, with a manageable adverse event (AE) profile. The most common AEs with RBX2660 were gastrointestinal in nature. Most AEs occurred during the first 2 weeks after treatment and were of mild or moderate severity.