Fecal microbiota spores, live
| Clinical data | |
|---|---|
| Trade names | Vowst |
| Other names | SER-109, fecal microbiota spores, live-brpk |
| Routes of administration |
By mouth |
| ATC code |
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| Legal status | |
| Legal status |
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Fecal microbiota spores, live, sold under the brand name Vowst, is a fecal microbiota product used for the prevention of recurrence of Clostridioides difficile infection (C. difficile). Fecal microbiota spores, live, contains live bacteria and is manufactured from human fecal matter that has been donated by qualified individuals.
Fecal microbiota spores, live was approved for medical use in the United States in April 2023. It is the first fecal microbiota product that is taken by mouth.
Medical uses
Fecal microbiota spores, live is 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 had recurrent C. difficile infection, 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 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 granted the application for fecal microbiota spores, live-brpk priority review, breakthrough therapy, and orphan drug designations. The FDA granted approval of Vowst to Seres Therapeutics Inc.
Further reading
- Feuerstadt P, Louie TJ, Lashner B, Wang EE, Diao L, Bryant JA, et al. (January 2022). "SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection". The New England Journal of Medicine. 386 (3): 220–229. doi:10.1056/NEJMoa2106516. PMID 35045228.