Live fecal microbiota spores, sold under the brand name Vowst, are a fecal microbiota product used to prevent the recurrence of ''Clostridioides difficile'' infection (''C. difficile''). Live fecal microbiota spores contain live bacteria and are manufactured from human fecal matter donated by qualified individuals. Vowst was approved for medical use in the United States in April 2023. It is the first fecal microbiota product that is taken

by mouth Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications. Oral administ ...

(orally).

Medical uses

Fecal microbiota spores (live) are indicated to prevent the recurrence of ''Clostridioides difficile'' infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

History

The safety of fecal microbiota spores (live) was evaluated in a randomized, double-blind, placebo-controlled clinical study and an open-label clinical study conducted in the US and Canada. The participants who suffered from recurrent ''C. difficile'' infection were subjected to 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 ''C. difficile'' infection received all scheduled doses of fecal microbiota spores, live. In an analysis among 90 recipients of fecal microbiota spores, live, when compared to 92 recipients of placebo, the most commonly reported side effects by recipients of fecal microbiota spores, live, which occurred at a greater frequency than reported by placebo recipients, were abdominal bloating, fatigue, constipation, chills and diarrhea. The effectiveness of fecal microbiota spores, live was evaluated in the randomized, placebo-controlled clinical study in which 89 participants received fecal microbiota spores, live 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%). The

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

granted the application for fecal microbiota spores, live-brpk

priority review Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...

breakthrough therapy Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "b ...

, and

orphan drug An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by th ...

designations. The FDA granted approval of Vowst to Seres Therapeutics Inc.

Medical uses

History

References

Further reading