Vowst photo pending
KEY POINTS
- Fecal microbiota spores, live-brpk goes by brand name Vowst and was studied as SER-109
- Is a product of Seres Therapeutics
- Manufactured from human fecal matter sourced from donors
- The spore suspension is generated by treating fecal matter with ethanol to kill organisms that are not spores, which is followed by filtration steps to remove solids and residual ethanol
- May carry an infection transmission risk (although screening is performed) as well as risk for allergen exposure
- The mechanism of action is not established
- FDA approved on April 26, 2023 for the prevention of recurrence of Clostridioides difficile (C. difficile) infection in individuals 18 years of age and older, following antibacterial treatment for recurrent C. difficile infection
- First orally administered preventative C. difficile option
- Not indicated for treatment of C. difficile infection
- Studied in patients with 3 or more episodes of C. difficile infection, finding recurrent C. difficile infection through 8 weeks in the intent to treat population of 11/89 (12.4%) for Vowst and 37/93 (39.8%) for placebo
- Through 12 weeks the rate of recurrence was 16/89 (18%) for Vowst and 43/93 (46.2%) for placebo
- Through 24 weeks the rate of recurrence was 19/89 (21.3%) for Vowst and 44/93 (47.3%) for placebo
- Dosage is 4 capsules oral once daily for 3 consecutive days
- Must complete treatment for an episode of recurrent C. difficile infection 2 to 4 days before initiating fecal microbiota spores
- Each dose should be taken on an empty stomach before the first meal of the day
- Patients should be instructed to drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose
- In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, which is not approved for this use)
- Storage of the container should be between 2° to 25°C (36° to 77°F) and it should not be frozen
- Supplied in bottles containing 12 capsules each
- The most common side effects are abdominal distention, fatigue, constipation, chills, and diarrhea
- Should not be administered concurrently with antibacterial drugs
- Cost of Vowst is yet to be released, but is expected to be expensive
RESOURCES
- Vowst Package Insert
- Vowst Patient Information Sheet
- FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection
- Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile InfectionA Phase 3, Open-Label, Single-Arm Trial
- SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection – NEJM 2022