{{Short description|Medication}} {{Use American English|date=April 2023}} {{Use dmy dates|date=April 2023}} {{Infobox drug | drug_name = | INN = | type = <!-- empty --> | image = | width = | alt = | caption =
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<!-- Clinical data --> | pronounce = | tradename = Vowst | Drugs.com = | MedlinePlus = | licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) --> | licence_EU = <!-- EMA uses INN (or special INN_EMA) --> | DailyMedID = <!-- DailyMed may use generic or brand name (generic name preferred) --> | licence_US = <!-- FDA may use generic or brand name (generic name preferred) --> | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU_comment = | pregnancy_category = | routes_of_administration = By mouth | class = | ATCvet = | ATC_prefix = None | ATC_suffix = | ATC_supplemental = | biosimilars =
<!-- Legal status --> | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> | legal_AU_comment = | legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> | legal_BR_comment = | legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_CA_comment = | legal_DE = <!-- Anlage I, II, III or Unscheduled --> | legal_DE_comment = | legal_NZ = <!-- Class A, B, C --> | legal_NZ_comment = | legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> | legal_UK_comment = | legal_US = Rx-only | legal_US_comment =<ref name="Vowst FDA label">{{cite web | title=Vowst- fecal microbiota spores, live-brpk capsule | website=DailyMed | date=21 April 2023 |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99e5a37a-930c-4641-bcdd-7013ec1c15fe | access-date=19 May 2023}}</ref> | legal_EU = | legal_EU_comment = | legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> | legal_UN_comment = | legal_status = <!-- For countries not listed above -->
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<!-- Identifiers --> | CAS_number = | CAS_supplemental = | PubChem = | IUPHAR_ligand = | DrugBank = | ChemSpiderID = | UNII = | KEGG = | ChEBI = | ChEMBL = | NIAID_ChemDB = | PDB_ligand = | synonyms = SER-109, fecal microbiota spores, live-brpk
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'''Live fecal microbiota spores,''' sold under the brand name '''Vowst''', are a fecal microbiota product used to prevent the recurrence of ''Clostridioides difficile'' infection (''C. difficile'').<ref name="Vowst FDA label" /><ref name="FDA PR 20230427">{{cite press release | title=FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection | website=U.S. Food and Drug Administration (FDA) | date=26 April 2023 |url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides | access-date=27 April 2023 | archive-date=26 April 2023 | archive-url=https://web.archive.org/web/20230426230158/https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides | url-status=dead }} {{PD-notice}}</ref>
Live fecal microbiota spores contain live bacteria and are manufactured from human fecal matter donated by qualified individuals.<ref name="FDA PR 20230427" />
Vowst was approved for medical use in the United States in April 2023.<ref name="Vowst FDA label" /><ref name="FDA PR 20230427" /><ref>{{cite press release | title=Seres Therapeutics and Nestlé Health Science Announce FDA Approval of Vowst (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI | publisher=Seres Therapeutics | via= Business Wire | date=26 April 2023 |url=https://www.businesswire.com/news/home/20230426006066/en/ | access-date=27 April 2023}}</ref> It is the first fecal microbiota product that is taken by mouth (orally).<ref name="FDA PR 20230427" />
== Medical uses == Fecal microbiota spores (live) are indicated to prevent the recurrence of ''Clostridioides difficile'' infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).<ref name="Vowst FDA label" /><ref>{{cite web | title=Vowst | website=U.S. Food and Drug Administration | date=26 April 2023 |url=https://www.fda.gov/vaccines-blood-biologics/vowst | access-date=27 April 2023 | archive-date=28 April 2023 | archive-url=https://web.archive.org/web/20230428050255/https://www.fda.gov/vaccines-blood-biologics/vowst | url-status=live }} {{PD-notice}}</ref>
== History == The safety of fecal microbiota spores (live) was evaluated in a randomized, double-blind, placebo-controlled clinical study and an open-label clinical study conducted in the US and Canada.<ref name="FDA PR 20230427" /> The participants who suffered from recurrent ''C. difficile'' infection were subjected to 48 to 96 hours post-antibacterial treatment and their symptoms were controlled.<ref name="FDA PR 20230427" />
Across both studies, 346 individuals 18 years of age and older with recurrent ''C. difficile'' infection received all scheduled doses of fecal microbiota spores, live.<ref name="FDA PR 20230427" /> In an analysis among 90 recipients of fecal microbiota spores, live, when compared to 92 recipients of placebo, the most commonly reported side effects by recipients of fecal microbiota spores, live, which occurred at a greater frequency than reported by placebo recipients, were abdominal bloating, fatigue, constipation, chills and diarrhea.<ref name="FDA PR 20230427" /> The effectiveness of fecal microbiota spores, live was evaluated in the randomized, placebo-controlled clinical study in which 89 participants received fecal microbiota spores, live and 93 participants received placebo.<ref name="FDA PR 20230427" /> Through eight weeks after treatment, CDI recurrence in Vowst-treated participants was lower compared to placebo-treated participants (12.4% compared to 39.8%).<ref name="FDA PR 20230427" />
The FDA granted the application for fecal microbiota spores, live-brpk priority review, breakthrough therapy, and orphan drug designations.<ref name="FDA PR 20230427" /> The FDA granted approval of Vowst to Seres Therapeutics Inc.<ref name="FDA PR 20230427" />
== References == {{reflist}}
== Further reading == * {{cite journal | vauthors = Feuerstadt P, Louie TJ, Lashner B, Wang EE, Diao L, Bryant JA, Sims M, Kraft CS, Cohen SH, Berenson CS, Korman LY, Ford CB, Litcofsky KD, Lombardo MJ, Wortman JR, Wu H, Auniņš JG, McChalicher CW, Winkler JA, McGovern BH, Trucksis M, Henn MR, von Moltke L | display-authors = 6 | title = SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection | journal = The New England Journal of Medicine | volume = 386 | issue = 3 | pages = 220–229 | date = January 2022 | pmid = 35045228 | doi = 10.1056/NEJMoa2106516 | doi-access = free | title-link = doi }}
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{{DEFAULTSORT:Fecal Microbiota Spores, Live}} Category:Feces Category:Gut flora bacteria Category:Orphan drugs