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Fidaxomicin

Clinical data
Routes of administration	Oral
Legal status
Legal status	US: ℞-only Phase III
Pharmacokinetic data
Excretion	Feces
Identifiers
IUPAC name 3-(((6-Deoxy-4-O-(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2-O-methyl-b-D-mannopyranosyl)oxy)-methyl)-12(R)--11(S)-ethyl-8(S)-hydroxy-18(S)-(1(R)-hydroxyethyl)-9,13,15-trimethyloxacyclooctadeca-3,5,9,13,15-pentaene-2-one
CAS Number	873857-62-6
PubChem CID	11528171
KEGG	D09394
ECHA InfoCard	100.220.590
Chemical and physical data
Formula	C52H74Cl2O18
Molar mass	1058.05 g·mol
(verify)

Fidaxomicin (also known as OPT-80 and PAR-101) is the first in a new class of narrow spectrum macrocyclic antibiotic drugs. It is non-systemic, meaning it is minimally absorbed into the bloodstream, it is bactericidal, and it has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the multiple species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of Clostridium difficile infection recurrence.

It is being developed by Optimer Pharmaceuticals for treatment of Clostridium difficile infection. It is administered orally.

It works by inhibiting the bacterial enzyme RNA polymerase, resulting in the death of Clostridium difficile. It is active against gram positive bacteria especially clostridia.

Clinical trials

Good results were reported in 2009 from a North American phase III trial comparing it with oral vancomycin for the treatment of Clostridium difficile Infection, or CDIThe study met its primary endpoint of clinical cure, showing that fidaxomicin was non inferior to oral vancomycin (92.1% vs. 89.8%). In addition, the study met its secondary endpoint of recurrence: 13.3% of the subjects had a recurrence with fidaxomicin vs. 24.0% with oral vancomycin, p=0.004. The study also met its exploratory endpoint of global cure (77.7% for fidaxomicin vs. 67.1% for vancomycin p=0.006. Clinical cure was defined as patients requiring no further CDI therapy two days after completion of study medication. Global cure was defined as patients who were cured at the end of therapy and did not have a recurrence in the next 4 weeks.

A second Phase 3 clinical trial of the same design is currently ongoing in North America and Europe. Fidaxomicin has been granted fast track status by the U.S. Food and Drug Administration (FDA).

Sept 2010 : Good combined results from the two phase 3 trials.

Target approval date is May 30, 2011.

References

1. Revill, P.; Serradell, N.; Bolos, J. (2006). "Tiacumicin B: macrolide antibiotic treatment of C. difficile-associated diarrhea". Drugs of the Future. 31 (6): 494–497.{{cite journal}}: CS1 maint: multiple names: authors list (link)
2. Louie, Thomas (2009-01). "OPT-80 Eliminates Clostridium difficile and Is Sparing of Bacteroides". Antimicrobial Agents and Chemotherapy. 535 (1): 261–263. doi:10.1128/AAC.01443-07. PMC 2612159. PMID 18955523. {{cite journal}}: |access-date= requires |url= (help); Check date values in: |date= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)
3. Johnson, Stuart (2009-06). "Recurrent Clostridium difficile infection: a review of risk factors, treatments, and outcomes". Journal of Infection. 58 (6): 403–410. doi:10.1016/j.jinf.2009.03.010. PMID 19394704. Retrieved 2009-11-10. {{cite journal}}: Check date values in: |date= (help); Cite has empty unknown parameter: |coauthors= (help)
4. Optimer's North American phase 3 Fidaxomicin study results presented at the 49th ICAAC, The Medical News, September 16, 2009
5. Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment, Reuters, May 17, 2009
6. Golan, Y. (2009-09). "ICAAC 2009" (Document). San Francisco, California: Interscience Conference on Antimicrobial Agents and ChemotherapyTemplate:Inconsistent citations {{cite document}}: Check date values in: |date= (help); Cite has empty unknown parameters: |coeditors=, |editor-first=, |format=, and |editor-last= (help); Unknown parameter |accessdate= ignored (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |contribution-url= ignored (help); Unknown parameter |contribution= ignored (help)CS1 maint: date and year (link) CS1 maint: postscript (link)
7. Gorbach, S. (2009-09). "ICAAC 2009" (Document). San Francisco, California: Interscience Conference on Antimicrobial Agents and Chemotherapy and American Society for MicrobiologyTemplate:Inconsistent citations {{cite document}}: Check date values in: |date= (help); Cite has empty unknown parameters: |coeditors=, |editor-first=, |format=, and |editor-last= (help); Unknown parameter |accessdate= ignored (help); Unknown parameter |coauthors= ignored (|author= suggested) (help); Unknown parameter |contribution-url= ignored (help); Unknown parameter |contribution= ignored (help)CS1 maint: date and year (link) CS1 maint: postscript (link)
8. ClinicalTrials.gov "PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)"
9. "ICAAC: Novel Drug Trumps C. Diff Standard". 15 Sep 2010.
10. "Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA". 23 Oct 2010.

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