WASHINGTON (AP) — U.S. officials have approved the first pharmaceutical version of so-called fecal transplant procedures that doctors are increasingly using to treat hard-to-treat intestinal infections.
The Food and Drug Administration on Wednesday approved Rebyota for adults who have trouble fighting off infections with Clostridium difficile, commonly called C. diff, a bacteria that causes nausea, cramps and diarrhea. The infection is particularly dangerous when it recurs and is associated with about 15,000 to 30,000 deaths annually.
For more than a decade, some American doctors have used stool samples from healthy donors to treat this condition. Healthy gut bacteria from donors have been shown to help recipients fight off C. diff bacteria. The procedure is becoming more common as many patients no longer respond to traditional antibiotics.
But the proliferation of stool banks and fecal transplant practitioners across the country has created regulatory headaches for the FDA, which traditionally does not regulate doctors’ medical procedures. The FDA rarely intervenes, provided stool donors are carefully screened for potential infectious diseases.
The new therapy from Ferring Pharmaceuticals Inc. is produced at a facility in Minnesota from stool donations that are screened for dozens of infections and viruses. The therapy is administered rectally by healthcare professionals as a one-time procedure.
The FDA said it approved the treatment based on results from two studies in which 70 percent of patients taking Rebyota saw their symptoms disappear after eight weeks, compared with 58 percent of patients receiving a placebo.
The new treatment is only for patients who have already had a course of antibiotics for a recurrent infection. The condition is more common in the elderly and people with weakened immune systems.
The Associated Press Health and Science Division is supported by the Science and Education Media Group of the Howard Hughes Medical Institute. AP is solely responsible for all content.
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