The U.S. Food and Drug Administration (FDA) has approved Vowst, the first oral-fecal microbiota product, to prevent the recurrence of Clostridioides difficile (C. difficile) infection in patients over the age of 18, following antibacterial treatment for recurrent CDI. This is a significant step forward in advancing patient care and accessibility, according to Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.
CDI, caused by the bacterium C. difficile, is a prevalent healthcare-associated infection in the United States, resulting in 15,000 to 30,000 fatalities yearly. Recurrent CDI, a condition where individuals may contract the infection again, often several times, is common after recovering from the initial infection.
The likelihood of subsequent recurrences rises with each subsequent infection, and there are limited treatment options for recurrent CDI. Fecal microbiota transplantation is believed to aid in the recovery of gut flora, reducing the likelihood of further CDI episodes.
Vowst is a medication administered orally for three consecutive days, consisting of four capsules taken once a day. It is made from human fecal matter donated by qualified individuals, which undergoes testing for transmissible pathogens. However, there remains a risk of transmitting infectious agents or containing food allergens, and the potential for Vowst to cause adverse reactions are unknown.
Two clinical studies were conducted in the U.S. and Canada to evaluate the safety and efficacy of Vowst. A total of 346 adults aged 18 or older with recurrent CDI received all scheduled doses of Vowst. Among 90 Vowst recipients, abdominal bloating, fatigue, constipation, chills, and diarrhea were the most frequently reported side effects. In a randomized, double-blind, placebo-controlled clinical study involving 89 Vowst-treated and 93 placebo-treated participants, CDI recurrence was lower in the Vowst-treated group than the placebo group (12.4% versus 39.8%) through eight weeks after treatment.
It is important to note that Vowst is not a cure for CDI, and there are risks associated with its use. Patients should be aware of the potential risks and benefits and should consult with their healthcare provider to determine if Vowst is appropriate for them.
In summary, the approval of Vowst represents a significant step forward in the prevention of recurrent CDI. While there are potential risks associated with its use, the benefits of Vowst may outweigh the risks for patients who have experienced this disease, which can be potentially life-threatening. Healthcare providers should be aware of Vowst as a treatment option for their patients with recurrent CDI.