FDA Approves First Fecal Microbiota Pill for Recurrent C. diff Infection

Clostridium difficile bacteria.

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The FDA has approved Vowst, the first oral fecal microbiota product, for the prevention of recurrence of Clostridioides difficile (“C. diff”) infection (CDI) in adults following antibacterial treatment for recurrent CDI.

CDI is a leading cause of infections acquired in healthcare settings, including hospitals and nursing homes. After recovering, individuals may get the infection again, and the risk of recurrence increases with each infection. The CDC estimates that there are about half a million infections a year, and one in six patients will have recurrence within eight weeks. Older adults are especially vulnerable; one in 11 patients aged 65 years and older with C. diff die within one month.

Current treatment options for recurrent CDI are limited. The approval of Vowst provides a new way to help prevent recurrent CDI.

“Our teams have vast experience in gastrointestinal disorders and are poised to engage with healthcare professionals to start addressing this critical need for patients. We expect Vowst to be available in June and look forward to helping patients.” Greg Behar, Chief Executive Officer of Nestlé Health Science, said in a press release.

Vowst is taken as four capsules by mouth once a day for three days. The manufacturer’s list price for Vowst will be $17,500 (wholesale acquisition cost), according to a presentation by Seres Therapeutics.

Vowst capsules contain live bacteria manufactured from human fecal matter donated by qualified individuals. The administration of fecal microbiota is thought to restore the gut flora and help prevent additional bouts of CDI. Although the donors and donated stool are tested for a panel of transmissible pathogens, Vowst may carry a risk of transmitting infections and may contain food allergens.

The safety and effectiveness of Vowst were evaluated in randomized, double-blind, placebo-controlled clinical trials conducted in the US and Canada. At eight weeks after treatment, the rate of CDI recurrence in Vowst-treated participants was 12.4%, while the recurrence rate among placebo-treated participants was 39.8%. The results were sustained at 24 weeks post-treatment.

In clinical trials, the most commonly reported side effects were bloating, fatigue, constipation, chills, and diarrhea.