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Revision as of 13:57, 23 October 2011 by CheMoBot (talk | contribs) (Updating {{drugbox}} (changes to verified and watched fields - updated 'KEGG_Ref', 'CAS_number_Ref') per Chem/Drugbox validation (report errors or bugs))(diff) ← Previous revision | Latest revision (diff) | Newer revision → (diff) Pharmaceutical compound | |
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| AHFS/Drugs.com | International Drug Names |
| Routes of administration | Oral |
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| Formula | C12H15NO5S |
| Molar mass | 285.317 g/mol g·mol |
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Faropenem is an orally-active beta-lactam antibiotic belonging to the penem group.
It is resistant to some forms of extended-spectrum beta-lactamase.
It is orally available.
Forms
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. (CID 636379 from PubChem)
- The prodrug form faropenem medoxomil (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 that this name was rejected by the FDA. (Q1 06 Investor Conf Call)(CID 6918218 from PubChem)
The company also stated their hope to have the product available for commercial sale months before the 2007 influenza season.
Clinical use
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 (NDA) dossier submitted included four proposed indications:
- acute bacterial sinusitis
- community acquired pneumonia
- acute exacerbations of chronic bronchitis
- uncomplicated skin and skin structure infections
History
FDA rejects Replidyne’s faropenem Louisville firm drug rejected; considered “nonapprovable’ 10/24/06 The US Food and Drug Administration (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
- Critchley IA, Brown SD, Traczewski MM, Tillotson GS, Janjic N (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.
{{cite journal}}: Unknown parameter|month=ignored (help)CS1 maint: multiple names: authors list (link) - Mushtaq S, Hope R, Warner M, Livermore DM (2007). "Activity of faropenem against cephalosporin-resistant Enterobacteriaceae". J. Antimicrob. Chemother. 59 (5): 1025–30. doi:10.1093/jac/dkm063. PMID 17353220.
{{cite journal}}: Unknown parameter|month=ignored (help)CS1 maint: multiple names: authors list (link) - Milazzo I, Blandino G, Caccamo F, Musumeci R, Nicoletti G, Speciale A (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.
{{cite journal}}: Unknown parameter|month=ignored (help)CS1 maint: multiple names: authors list (link) - Gettig JP, Crank CW, Philbrick AH (2008). "Faropenem medoxomil". Ann Pharmacother. 42 (1): 80–90. doi:10.1345/aph.1G232. PMID 18094341.
{{cite journal}}: Unknown parameter|month=ignored (help)CS1 maint: multiple names: authors list (link)