On Wednesday, U.S. health officials approved the first medication manufactured from good bacteria discovered in human excrement to prevent serious gut infections – a more straightforward approach to undertaking fecal transplants.
Seres Therapeutics’ new treatment is a simplified, extensively tested version of stool-based methods that certain medical practitioners have used to aid patients for over a decade.
The Food and Drug Administration has approved the capsules for persons 18 and older at risk of recurrent infections with Clostridium difficile, a germ that can cause severe nausea, cramps, and diarrhea.
C. When diff recurs, it is especially hazardous, resulting in 15,000 to 30,000 fatalities per year. Antibiotics can kill it, but they also kill the healthy bacteria in the gut.
Some doctors began reporting success with fecal transplants — utilizing stool from a healthy donor — more than ten years ago to restore the gut’s healthy balance and avoid reinfections.
Last year, the FDA authorized Ferring Pharmaceuticals’ first pharmaceutical-grade medication version. However, that company’s product must be given through the rectum, like most original procedures.
Based in Cambridge, Massachusetts, Seres will position their medicine as a less invasive choice. The medication will be marketed under the brand name Vowst and will consist of four daily capsules for three days.
Both new FDA approvals result from years of pharmaceutical industry study into the microbiome, a population of bacteria, viruses, and fungi that dwell in the human body.
Most fecal transplants are currently delivered by a stool bank network that has sprung up at medical institutions and hospitals nationwide.
While the advent of new FDA-approved treatments is expected to reduce demand for stool bank donations, some are planning to remain open.
OpenBiome, the nation’s largest stool bank, has stated that it will continue to serve patients ineligible for FDA-approved products, such as children and adults with treatment-resistant conditions.
More than 65,000 stool samples for C. Various patients have been treated since 2013.
“OpenBiome is committed to maintaining safe access to ‘fecal transplantation’ for these patients as a vital last line of defense,” stated the group’s medical director, Dr. Majdi Osman.
The regular stool treatment from OpenBiome costs less than $1,700 and is usually delivered as a frozen solution within days of ordering. In a statement issued Wednesday evening, Seres did not reveal the pricing of its capsules.
“We want to make the commercial experience for physicians and patients as easy as possible,” said Eric Shaff, the company’s CEO, in an interview before the announcement. “In our opinion, one aspect of the value we provide is ease of administration.”
Seres will co-market the medication with Swiss food giant Nestle, who will also split revenues. Nestle will pay Seres a $125 million milestone payment with the FDA clearance.