The FDA has approved Vowst, the first-ever pill made from donated human feces, for people aged 18 and above.

FDA Approves Poop-Made Medication

The US Food and Drug Administration (FDA) has announced the approval of the first-ever pill made from donated human feces, called Vowst, for use in people aged 18 and above.

Vowst is made by Seres Therapeutics in collaboration with Nestlé Health Science.

Vowst is the second human feces-derived treatment ever approved by the FDA, following an enema-based treatment cleared for use in December 2022.

Prior to these approvals, fecal microbiota transplants were considered investigational treatments and were harder for patients to access and often not covered by insurance.

Like the previously approved enema treatment, Vowst also contains live bacteria and has been approved as a preventive treatment for recurrent infections with the bacterium Clostridioides difficile (C. diff).

C. diff infection is often acquired in healthcare settings after patients have taken antibiotics for a different infection. Antibiotics can disrupt the balance of bacteria in the gut, allowing C. diff to proliferate.

The rapidly replicating bacteria secrete toxins that can lead to diarrhea, abdominal pain, fever, colitis, and, in some cases, organ failure and death. C. diff infections are associated with about 15,000 to 30,000 deaths a year in the US.

Fecal Products Offer a “New Way” of Treatment

Fecal microbiota products made from healthy human gut bacteria offer a new way to prevent recurrent C. diff by essentially replenishing the gut microbiome. With the approval of Vowst, there’s now a version of the treatment that can be taken orally, rather than being administered as a liquid treatment into a patient’s rectum.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, called the availability of an orally administered fecal microbiota product a significant step forward in advancing patient care and accessibility for individuals who have experienced this potentially life-threatening disease.

The Vowst treatment regimen involves taking four capsules once a day for three days in a row. Patients start taking the drug two to four days after finishing a course of antibiotics for C. diff.

In clinical trials, the most common side effects of Vowst were abdominal bloating, fatigue, constipation, chills, and diarrhea.

Side Effects

These side effects occurred more frequently in treated patients than in placebo recipients. In a comparison of about 90 people who received the pills and 90 who didn’t, those in the treated group had a 12.4% rate of recurrent C. diff infection within eight weeks of recovering from an initial bout of the infection, whereas the untreated group had a 39.8% rate of recurrence.

The donated feces used to make the pills are carefully screened for transmissible pathogens before being used in manufacturing, but the FDA cautioned that taking Vowst still carries some risk of being exposed to pathogens, as well as to food allergens.

However, the approval of Vowst marks a significant milestone in advancing patient care and accessibility for individuals who have experienced this potentially life-threatening disease.

Nestlé Health Science Involvement

The newly approved pill called Vowst will receive marketing support from food conglomerate Nestlé under a co-commercialization and profit-sharing agreement signed in 2021.

Nestlé Health Science already employs a gastroenterology sales team responsible for promoting various gut health products, such as the Fiber Choice probiotic and fiber supplement line and Zenpep, a prescription medication designed for people with pancreatic enzyme deficiencies.

The addition of Vowst to the sales team’s portfolio follows its recent approval by the US Food and Drug Administration, which will now allow for promotion of the product to individuals aged 18 and above. Read more about Nestle’s involvement here.

Vowst is expected to be available sometime in June 2023. You can read, here, for Full Prescribing Information and Patient Information.

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