FDA Approves First Pill for Fecal Transplant Therapy
29 Apr 2023 • The U.S. Food and Drug Administration on Wednesday approved the first pill form of fecal microbiota — similar to what is known as fecal transplant therapy — to treat Clostridioides difficile. The drug, Vowst, is approved to prevent recurrence of C. difficile in people who have already had standard antibacterial treatment for recurrent infection. It contains live gut bacteria from stool samples donated by healthy people.
C. difficile infection causes diarrhea, abdominal pain, fever, and sometimes organ failure and death. Before now, such treatments have been administered rectally. Last year, the FDA approved another pharmaceutical-grade product to fight C. difficile, but it is delivered rectally.
The FDA approval of Vowst was based on a randomized clinical trial and an open-label clinical study. In the randomized trial in which 89 participants received Vowst and 93 received a placebo, the recurrence of infection was lower with the pill after eight weeks, at 12.4 percent for the medication group versus 39.8 percent for the placebo group.
Eligible patients age 18 years and older take four capsules of Vowst daily for three consecutive days. Although donors and their stool are screened for pathogens before the stool is processed for the medication, there is a risk that someone can get an illness through the pill, the FDA noted.
Source: Physician's Weekly | Read full article