FDA Approves New Oral Treatment to Prevent C.Diff Recurrence

The U.S. Food and Drug Administration (FDA) approved the first fecal microbiota product to be taken orally to prevent recurrence of clostridioides difficile (C. diff) infection, as announced in a FDA press release on April 26, 2023. The fecal microbiota product, named Vowst, can be safely consumed by adults 18 years and older, after the antibacterial treatment for recurrent C.diff infection.

One of the most common health care-associated infections in the United States, C.diff is known to cause roughly 15,000 to 30,000 deaths each year, according to the FDA. “Certain situations, such as taking antibiotics to treat an infection, can impact the gut microbiome and change the balance of microorganisms in the gut, allowing C. diff to multiply and release toxins causing diarrhea, abdominal pain, and fever,” read the release.

C.diff infections are known to be recurrent. Even after recovering from the infection, whether it is through hospitalization, surgery or antibacterial treatment, patients can experience recurrent C.diff infection. However, administering the new fecal microbiota orally to the specific group of patients may “facilitate restoration of the gut flora to prevent further episodes.”

The dosing regimen is 4 capsules taken once daily, orally, for 3 consecutive days.

—Priyam Vora

Reference:
FDA approves first orally administered fecal microbiota product for the prevention of recurrence of clostridioides difficile Infection. FDA news release. April 26, 2023.