The Food and Drug Administration (FDA), a US agency similar to Anvisa, approved the use of the first drug made from beneficial bacteria found in human feces. The drug is indicated to combat serious intestinal infections and is intended to replace the need for a stool transplant. The drug will be marketed under the name Vowst and is administered orally.
The medicine is indicated for recurrent infections by the bacteria Clostridium difficile. Resistant to treatments, the bacteria kills the microbiota of the intestine and causes colic, nausea and intense diarrhea. The only treatment for the infection before the drug was approved was a stool transplant.
“The feasibility of this medicine with fecal microbiota and oral use is a significant step forward in the treatment and care of patients living with diseases of the Clostridium difficile even life-threatening,” FDA Director Peter Marks said in a press release.
The FDA statement informs that at least 15,000 people die in the US every year from infections that could be treated more easily with the new drug. There is no data on the subject in Brazil.
How does the medicine work?
The remedy can be used by anyone over the age of 18 and must be taken once a day for three consecutive days. During the clinical study, researchers found that the drug worked in 88% of the cases analyzed.
The drug has effects similar to those of a stool transplant, when stool from a healthy volunteer is treated, frozen and injected via colonoscopy into a sick patient. In Vowst, the fecal microbiota is condensed into pills, which makes the storage and administration of the medicine simpler.
Like the transplant, however, using Vowst can be dangerous for those with food allergies, the FDA advises.
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