The US Food and Drug Administration (FDA) has issued new draft guidance with advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI).
The draft provides recommendations for designing these trials and covers trial populations, efficacy and safety endpoints, nonclinical studies, and pharmacokinetic studies. The guidance does not address fecal microbiota transplant products.
CDI is an anaerobic, gram-positive, spore-forming bacterium that is a common cause of healthcare-associated diarrhea. The US Center for Disease Control and Prevention (CDC) deemed C. difficile as ‘threat-level urgent’ in its 2019 Antimicrobial Threats Report and estimates that C. difficile leads to the hospitalizations of 223,900 individuals resulting in 12,800 deaths per year.
The guidance addresses the development of small molecule drugs and biological products for treating CDI, reducing the recurrence of CDI, treating and preventing the recurrence of CDI, and preventing CDI in patients at risk…
