FDA Approves First Poop-Based Oral Therapy Bacterial Condition

WASHINGTON — The Food and Drug Administration on Wednesday approved the first oral fecal microbiota treatment for preventing recurrent Clostridium difficile colitis infections in adults.

Clostridium difficile colitis, caused by the bacterium C. difficile, is one of the most common health-care-associated infections in the United States and is a factor in 15,000 to 30,000 deaths annually. 

The risk factors associated with the condition increase after age 65.

The new therapy approved by FDA, SER-109, goes by the trade name Vowst and is manufactured by Seres Therapeutics Inc.

It is being suggested for use in patients over the age of 18 who have already received a course of antibiotics for recurrent infections.

For the treatment to be effective, patients must take four pills once a day for three consecutive days, the FDA said.

“Today’s approval provides patients and health care providers a new way to help prevent recurrent C. difficile infection,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

“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,” Marks said.

Vowst contains live bacteria from donor fecal matter, with the donors and stool screened for a wide range of pathogens. 

Despite that, the agency warns that the product carries the potential risk of transmitting infectious agents or food allergens.

The safety of Vowst was evaluated in a randomized, double-blind, placebo-controlled clinical study and an open-label clinical study conducted in the U.S. and Canada. 

The participants had recurrent CDI, were 48 to 96 hours post-antibacterial treatment and their symptoms were controlled. Across both studies, 346 individuals 18 years of age and older with recurrent CDI received all scheduled doses of Vowst. 

In an analysis among 90 Vowst recipients, when compared to 92 placebo recipients, the most commonly reported side effects by Vowst recipients, which occurred at a greater frequency than reported by placebo recipients, were abdominal bloating, fatigue, constipation, chills and diarrhea. 

The effectiveness of Vowst was evaluated in the randomized, placebo-controlled clinical study in which 89 participants received Vowst and 93 participants received placebo. Through eight weeks after treatment, CDI recurrence in Vowst-treated participants was lower compared to placebo-treated participants (12.4% compared to 39.8%).

Dan can be reached at [email protected] and @DanMcCue