First Oral Fecal Microbiota Product Wins FDA Approval

By Jonathan Springston, Editor, Relias Media

The FDA has approved Vowst, the first oral fecal microbiota product to prevent the recurrence of Clostridioides difficile infection (CDI), one of the most common healthcare-associated infections in the United States.

Vowst contains live bacteria from donated human fecal matter. Patients take four capsules once a day for three consecutive days. Researchers believe this regimen improves gut flora, which can prevent recurrent CDI (rCDI).

In two safety evaluation studies, the authors reported the common side effects of Vowst were abdominal bloating, chills, constipation, diarrhea, and fatigue. The FDA notes donated stool samples that comprise Vowst are tested for transmissible pathogens, but it is possible for the samples to carry infectious agents.

In an effectiveness study, the authors reported patients treated with Vowst experienced rCDI at a lower rate than those treated with placebo. In the just-related May issue of Infectious Disease Alert, author Richard Watkins, MD, MS, FACP, FIDSA, FISAC, analyzed this work. Although he raised some concerns about the limited period of the research (eight weeks) and some methodologies, Watkins called Vowst “a welcome addition to the therapeutic armamentarium for rCDI.”

“Recurrent CDI can be a devastating disease physically, mentally, and financially for patients and a considerable burden on the healthcare system. The positive results reported by Garey and colleagues are encouraging news in the struggle against rCDI,” Watkins wrote. “Physicians treating patients with rCDI primarily think about the disease in clinical terms, such as improvement in signs and symptoms. On the other hand, patients are affected not only by the clinical manifestations, but also by the social and emotional factors that accompany rCDI. Indeed, improving [health-related quality of life] is an important objective for the overall management of patients with rCDI.”

More details on Vowst will be available in an upcoming “Pharmacology Update” feature, which appears in each issue of Internal Medicine Alert.