Rebiotix announced that the FDA has granted Fast Track designation for the investigational RBX2660 (microbiota suspension), intended for the treatment of recurrent Clostridium difficile infection (CDI). RBX2660, an intestinal preparation containing live microbes, is being investigated to assess its safety and efficacy in the treatment of recurrent Clostridium difficile-associated diarrhea.
CDI, which is characterized by watery diarrhea and abdominal pain, has been linked to over 14,000 deaths annually in the U.S. and has become the most common healthcare-associated infection in some parts of the country, surpassing methicillin-resistant Staphylococcus aureus (MRSA) infections. Currently, there are few evidence-based approaches to the treatment of multiply-recurrent CDI.
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