FDA Approves First Pill for Fecal Transplant Therapy

FDA Approves First Pill for Fecal Transplant Therapy

The U.S. Food and Drug Administration on Wednesday approved the first pill form of fecal microbiota — similar to what’s known as fecal transplant therapy — to treat the bacterial infection Clostridioides difficile (C. difficile) infection (CDI) following antibacterial treatment for recurrent CDI in patients aged 18 and over.

CDI is caused by C. difficile, a bacterium which flourishes in the human intestinal tract when the balance of natural microorganisms is affected, commonly by antibiotics. C. difficile releases toxins which cause diarrhoea, abdominal pain, fever and, in serious cases, organ failure and death. After recovering from CDI, individuals may get the infection again multiple times, known as recurrent CDI.

Vowst is a faecal microbiota regimen containing live bacteria manufactured from donated faecal matter from healthy individuals. The treatment includes four capsules taken once daily for three consecutive days.