FDA Approves First Pill for Fecal Transplant Therapy

THURSDAY, April 27, 2023 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved the first pill form of fecal microbiota -- similar to what is known as fecal transplant therapy -- to treat Clostridioides difficile.

The drug, Vowst, is approved to prevent recurrence of C. difficile in people who have already had standard antibacterial treatment for recurrent infection. It contains live gut bacteria from stool samples donated by healthy people.

"Today's approval provides patients and health care providers a new way to help prevent recurrent C. difficile infection," Peter Marks, M.D., of the FDA Center for Biologics Evaluation and Research, said in a news release announcing the approval. "The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening."

C. difficile infection causes diarrhea, abdominal pain, fever, and sometimes organ failure and death. Each time someone gets infected, the risk for reinfection grows. But treatment with fecal microbiota can help restore a person's normal gut bacteria. Before now, such treatments have been administered rectally. Last year, the FDA approved another pharmaceutical-grade product to fight C. difficile, but it is delivered rectally.

The FDA approval of Vowst was based on a randomized clinical trial and an open-label clinical study. In the randomized trial in which 89 participants received Vowst and 93 received a placebo, the recurrence of infection was lower with the pill after eight weeks, at 12.4 percent for the medication group versus 39.8 percent for the placebo group. Another analysis of 90 patients who received Vowst, compared with 92 who received a placebo, revealed that side effects included bloating, fatigue, constipation, chills, and diarrhea.

Eligible patients age 18 years and older take four capsules of Vowst daily for three consecutive days. Although donors and their stool are screened for pathogens before the stool is processed for the medication, there is a risk that someone can get an illness through the pill, the FDA noted. Vowst may also contain food allergens.

Approval of Vowst was granted to Seres Therapeutics.

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