Washington. US health authorities yesterday approved the first pill made from beneficial bacteria found in human feces to combat dangerous intestinal infections, an easy option for fecal microbiota transplants.
The new treatment from Seres Therapeutics provides a more rigorously tested and simpler version of stool-based procedures that some specialists have used for more than a decade to help patients.
The Food and Drug Administration (FDA) has given the go-ahead for the use of the capsules to treat adults with possible problems caused by the Clostridium difficile, such as severe nausea, cramps, and diarrhea.
This bacterium is especially dangerous if there is a recurrence, and causes between 15,000 and 30,000 deaths per year. It can be killed with antibiotics, but antibiotics also destroy the beneficial bacteria that live in the gut, which can make it more susceptible to future infections. The new capsules are approved for patients who have already received antibiotic treatment.
More than 10 years ago, some doctors began to report the efficacy of fecal microbiota transplants, using feces from a healthy donor, to restore balance to the gut and prevent reinfections.
The FDA last year approved the first pharmaceutical-grade version of the treatment from another company, Ferring Pharmaceuticals. However, the product – like most of the original procedures – is delivered via colonoscopy.
Cambridge, Massachusetts-based Seres will market its drug as a less invasive option. It will be sold under the brand name Vowst, and his regimen involves taking four capsules a day for three consecutive days.
The two approved options are the product of years of research into the microbiome, the community of bacteria, viruses and fungi that inhabit the intestine.
We want to make the business experience for doctors and patients as easy as possible.
said Eric Shaff, the company’s CEO, in an interview prior to the announcement.