Vowst™ (fecal microbiota spores, live-brpk) is now available to prevent the recurrence of Clostridioides difficile infection (CDI) in adults 18 years of age and older following antibacterial treatment for recurrent CDI.
Vowst is a bacterial spore suspension in capsules for oral administration. It contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors. The product is not indicated for the treatment of CDI.
The Food and Drug Administration (FDA) approved Vowst based on data from the phase 3 ECOSPOR III study (ClinicalTrials.gov Identifier: NCT03183128), which included adults with a confirmed diagnosis of recurrent CDI who had a total of at least 3 episodes of CDI within 12 months.
Findings showed that the CDI recurrence rates were significantly lower in the Vowst treatment arm at 8, 12, and 24 weeks posttreatment compared with the placebo arm. The most common adverse reactions reported were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
Vowst is supplied in a bottle containing 12 capsules; the dosage of is 4 capsules taken orally once daily for 3 consecutive days. Antibacterial treatment for recurrent CDI should be completed 2 to 4 days prior to initiating treatment with Vowst.
“The commercial availability of Vowst provides a new oral dosing option that has demonstrated efficacy in the prevention of further recurrences of rCDI, including those who have experienced a first recurrence,” said Eric Shaff, President and CEO at Seres. “We look forward to helping patients who have this potentially life-threatening disease.”
The Company is offering assistance to eligible patients through the Vowst Voyage Support Program.
This article originally appeared on MPR
Seres Therapeutics and Nestlé Health Science announce US commercial availability of Vowst™, the first and only FDA-approved microbiota-based oral therapeutic for prevention of recurrence of difficile infection. News release. Seres Therapeutics and Nestlé Health Science. Accessed June 5, 2023. https://www.businesswire.com/news/home/20230605005120/en/Seres-Therapeutics-and-Nestl%C3%A9-Health-Science-Announce-U.S.-Commercial-Availability-of-VOWST%E2%84%A2-the-First-and-Only-FDA-Approved-Microbiota-Based-Oral-Therapeutic-for-Prevention-of-Recurrence-of-C.-Difficile-Infection.