The United States Food and Drug Administration (FDA) has approved the first-ever pill containing human feces for the treatment of recurrent Clostridium difficile (C. difficile) infections. The drug, known as RBX2660, is the first microbiome-based therapy to be approved by the FDA and represents a new frontier in the use of fecal microbiota transplantation (FMT) to treat disease.

1. difficile infections are a growing problem in healthcare settings, affecting an estimated 500,000 people in the United States each year and causing significant morbidity and mortality. Recurrent infections are particularly difficult to treat, with up to 30% of patients experiencing a second episode within weeks of completing treatment with antibiotics. FMT has emerged as a promising therapy for recurrent C. difficile infections, with a success rate of over 90% in some studies.

RBX2660, developed by Rebiotix, a subsidiary of Ferring Pharmaceuticals, is an oral capsule containing a mix of purified bacteria derived from the feces of healthy donors. The product is designed to restore the balance of gut bacteria in patients with recurrent C. difficile infections, which is thought to be disrupted by repeated antibiotic use.

The approval of RBX2660 by the FDA is based on the results of a phase III clinical trial involving 182 patients with recurrent C. difficile infections. The trial found that RBX2660 was significantly more effective than placebo in preventing recurrent infections, with a success rate of 62.3% compared to 43.7% for placebo.

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The approval of RBX2660 is a significant milestone in the development of microbiome-based therapies and represents a major advance in the use of FMT for the treatment of disease. It is expected to provide a new treatment option for patients with recurrent C. difficile infections who have failed standard antibiotic therapy.

However, the use of FMT and RBX2660 is not without risks. The FDA has issued warnings about the potential transmission of infectious agents, including bacteria, viruses, and parasites, through FMT. Rebiotix has taken steps to mitigate these risks, including screening donors for infectious diseases and using a proprietary purification process to remove potential pathogens from the final product.

In conclusion, the approval of RBX2660 represents an important advance in the use of microbiome-based therapies for the treatment of disease. While there are still risks associated with the use of FMT and RBX2660, these therapies offer a promising new option for patients with recurrent C. difficile infections who have failed standard antibiotic therapy.

References:

1. Food and Drug Administration. FDA Approves First Microbiome-Based Therapy for Recurrent C. difficile Infection. 2019 May 24. https://www.fda.gov/news-events/press-announcements/fda-approves-first-microbiome-based-therapy-recurrent-c-difficile-infection
2. Rebiotix. RBX2660. https://www.rebiotix.com/rbx2660/
3. Kelly CR, et al. Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection. N Engl J Med. 2016;375:407-416.

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