Faropenem

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Faropenem
Faropenem.svg
Clinical data
AHFS/Drugs.com International Drug Names
Legal status ?
Routes Oral
Identifiers
CAS number 106560-14-9 N
ATC code J01DI03
PubChem CID 65894
ChemSpider 59303 YesY
UNII F52Y83BGH3 YesY
ChEBI CHEBI:51257 YesY
ChEMBL CHEMBL556262 YesY
Chemical data
Formula C12H15NO5S 
Mol. mass 285.317 g/mol
 N (what is this?)  (verify)

Faropenem is an orally active beta-lactam antibiotic belonging to the penem group.[1] It is resistant to some forms of extended-spectrum beta-lactamase.[2] It is available for oral use.[3]

Forms[edit]

Faropenem was developed by Daiichi Asubio Pharma, which markets it in two forms.

  • The sodium salt faropenem sodium, available under the trade name Farom, has been marketed in Japan since 1997. (PubChem 636379)
  • The prodrug form faropenem medoxomil[4] (also known as faropenem daloxate) has been licensed from Daiichi Asubio Pharma by Replidyne, which plans to market it in conjunction with Forest Pharmaceuticals. The trade name proposed for the product was Orapem, but company officials recently announced this name was rejected by the FDA.[5]

Clinical use[edit]

Faropenem has yet to receive marketing approval in the United States, and was submitted for consideration by the United States Food and Drug Administration (FDA) on 20 December 2005. The new drug application dossier submitted included these proposed indications:

  • acute bacterial sinusitis
  • community-acquired pneumonia
  • acute exacerbations of chronic bronchitis
  • uncomplicated skin and skin structure infections
  • urinary tract infections

History[edit]

The FDA refused to approve faropenem, an antibiotic manufactured by Louisville-based Replidyne. The FDA said the drug was “nonapprovable”, but did not refer to specific safety concerns about the product. The company will have to conduct new studies and clinical trials, lasting an estimated two more years, to prove the drug treats community-acquired pneumonia, bacterial sinusitis, chronic bronchitis, and skin infections.

References[edit]

  1. ^ Critchley IA, Brown SD, Traczewski MM, Tillotson GS, Janjic N (December 2007). "National and regional assessment of antimicrobial resistance among community-acquired respiratory tract pathogens identified in a 2005-2006 U.S. Faropenem surveillance study". Antimicrob. Agents Chemother. 51 (12): 4382–9. doi:10.1128/AAC.00971-07. PMC 2168020. PMID 17908940. 
  2. ^ Mushtaq S, Hope R, Warner M, Livermore DM (May 2007). "Activity of faropenem against cephalosporin-resistant Enterobacteriaceae". J. Antimicrob. Chemother. 59 (5): 1025–30. doi:10.1093/jac/dkm063. PMID 17353220. 
  3. ^ Milazzo I, Blandino G, Caccamo F, Musumeci R, Nicoletti G, Speciale A (March 2003). "Faropenem, a new oral penem: antibacterial activity against selected anaerobic and fastidious periodontal isolates". J. Antimicrob. Chemother. 51 (3): 721–5. doi:10.1093/jac/dkg120. PMID 12615878. 
  4. ^ Gettig JP, Crank CW, Philbrick AH (January 2008). "Faropenem medoxomil". Ann Pharmacother 42 (1): 80–90. doi:10.1345/aph.1G232. PMID 18094341. 
  5. ^ (Q1 06 Investor Conf Call)(PubChem 6918218)

External links[edit]