FDA Approves New Pill for Clostridioides Difficile Infection: A Game-Changer for Gut Health

One of the groups of dietary ingredients that have undergone the most research is probiotics, and translational science has backed up their advantages. The need for clear, unified laws and claims to make it easier to distribute foods and dietary supplements containing probiotics to customers worldwide is highlighted by the fact that current differing global standards present hurdles to assuring consumer access to safe, high-quality probiotic products.

C. Difficile Bacilli

There are numerous over-the-counter probiotic food additives available, and the FDA just approved the first oral microbiome for therapeutic use. This product was created to prevent the recurrence of Clostridioides difficile infection. While antibiotics are generally successful in eradicating C. difficile, they also interfere with the ecosystem of the gut microbiome. Seres Therapeutics’ live microbiome capsule Vowst might just be the solution to this.

Microbiota spores from feces

The concept was inspired by fecal transplants, which have been utilized in clinical practice for a long time with no FDA regulation. Vowst is a standardized therapy that has gone through a rigorous FDA examination, despite the fact that it was also developed using microbiota spores found in donor feces. This is the first oral microbiota therapy that the FDA has approved.

In 2023, Seres predicts that there will be roughly 156,000 recurrent C. difficile cases in the United States, based on data from the Centers for Disease Control and Prevention (CDC). Vowst outperformed the placebo in ECOSPOR III, a phase 3 trial, in lowering the risk of recurrent C. difficile infections. Recurrence was experienced by 12% of patients in the Vowst group and 40% of patients in the placebo group eight weeks following treatment.

Vowst is Seres Therapeutics’ first product and they will have marketing help from food giant, Nestlé. Seres will benefit from Nestlé’s vast marketing resources thanks to a co-commercialization and profit-sharing agreement that was signed in 2021. A gastrointestinal sales team for Nestlé Health Science currently promotes a number of gut health products, such as the Fiber Choice line of probiotics, fiber supplements, and Zenpep, a prescription medication for those who have pancreatic enzyme deficiencies and have trouble correctly digesting food. The sales team will advertise Vowst after the FDA gave its approval.

The partnership between Nestlé and Seres dates back further; the two signed a strategic agreement on microbiome-based therapeutics outside of North America in 2016. Midway through 2021, the corporations expanded Vowst into the US and Canada. To oversee the implementation of Vowst, Seres, and Nestlé have formed a joint committee. Seres has been in charge of medical affairs and regulatory filings and is primarily in charge of manufacturing. Nestlé’s contribution consists primarily of its commercial infrastructure, which includes sales representatives and reimbursement capabilities. Before the approval, the manufacturing scale-up, payer discussions, and medical education began, according to Shaff.

Clinical significance

Having more treatment options for challenging cases of C. difficile is beneficial to patients. The oral route of administration, tolerability, and effectiveness of Vowst set it clearly apart from other probiotics.

Conclusion

The development of a fecal microbiota product that may be consumed orally represents a substantial improvement in patient care and accessibility for those who have endured this potentially fatal illness. We look forward to more strides in this field.