First pill for fecal transplants gets FDA approval

WASHINGTON — U.S. health officials on Wednesday approved the first pill made from healthy bacteria found in human waste to fight dangerous intestinal infections — an easier way to perform so-called fecal transplants.

The new treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some medical specialists have been using for more than a decade to help patients.

The Food and Drug Administration has authorized the capsules for adults 18 and older who are at risk for repeated infections with Clostridium difficile, a bacteria that can cause severe nausea, cramps and diarrhea.

C. diff is particularly dangerous when reproducing, causing between 15,000 and 30,000 deaths per year. It can be killed with antibiotics, but they also destroy the good bacteria that live in the gut, making it more vulnerable to future infections. The new capsules are approved for patients who have already received antibiotic treatment.

More than 10 years ago, some doctors began reporting the success of fecal transplants — using stool from a healthy donor — to restore the gut’s healthy balance and prevent reinfections.

The FDA last year approved the first pharmaceutical-grade version of the treatment from rival drugmaker Ferring Pharmaceuticals. But this company’s product – like most original procedures – must be administered rectally.

Seres, based in Cambridge, Massachusetts, will market its drug as a less invasive option. The treatment will be sold under the Vowst brand and comes as a regimen of four daily capsules taken for three consecutive days.

The two recent FDA approvals are the product of years of pharmaceutical industry research into the microbiome, the community of bacteria, viruses, and fungi that live in the gut.

Currently, most fecal transplants are provided by a network of stool banks that have been popping up in medical facilities and hospitals across the country.

While the availability of new FDA-approved options should reduce demand for stool bank donations, some plan to stay open.

OpenBiome, the largest stool bank in the United States, said it will continue to serve patients who are not eligible for FDA-approved products, such as children and adults with treatment-resistant cases. It has provided more than 65,000 stool samples for C. diff patients since 2013.

“OpenBiome is committed to maintaining safe access to ‘fecal transplantation’ for these patients as a vital last line of defense,” said Dr. Majdi Osman, the group’s chief medical officer.

OpenBiome’s standard stool treatment costs less than $1,700 and usually ships as a frozen solution within days of ordering. Seres did not disclose the price it will charge for its capsules in a statement late Wednesday.

“We want to make the commercial experience for physicians and patients as easy as possible,” said Eric Shaff, CEO of the company, in an interview ahead of the announcement. “Ease of administration – in our view – is one aspect of the value we provide.”

Oversight of the nascent U.S. stool bank industry has created regulatory headaches for the FDA, which has traditionally not vetted in-house products and procedures used in medical offices. Early in the trend, the FDA warned consumers about the risks of potential infections from fecal transplants as some people searched for questionable “do it yourself” methods from videos and websites. .

Seres executives say their manufacturing process relies on the same techniques and equipment used to purify blood products and other biological therapies.

The company begins with stool provided by a small group of donors who are screened for various risks and health conditions. Their stools are also tested for dozens of potential viruses, infections and parasites.

The company then processes the samples to remove waste, isolate healthy bacteria, and kill any other lingering organisms. Thousands of capsules can be made from each stool sample, making it a more efficient process than current fecal transplants, the company says.

The FDA warned in its approval announcement that the drug “may carry a risk of transmitting infectious agents. It is also possible that Vowst contains food allergens,” the agency noted.

The FDA approved the treatment based on a study of 180 patients in which nearly 88% of patients taking the capsules experienced no reinfection after 8 weeks, compared with 60% of those who received dummy pills.

Common side effects included abdominal swelling, constipation, and diarrhea.


This story has been corrected to show that Eric Shaff is the CEO of Seres Therapeutics, not its CFO.


Follow Matthew Perrone on Twitter: @AP_FDAwriter ___

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Science and Education Media Group. The AP is solely responsible for all content.

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