Faropenem is an orally active
beta-lactam antibiotic
β-lactam antibiotics (beta-lactam antibiotics) are antibiotics that contain a beta-lactam ring in their chemical
structure. This includes penicillin derivatives (penams), cephalosporins and cephamycins (cephems), monobactams, carbapenems and ...
belonging to the
penem group.
It is resistant to some forms of extended-spectrum
beta-lactamase
Beta-lactamases, (β-lactamases) are enzymes () produced by bacteria that provide multi-resistance to beta-lactam antibiotics such as penicillins, cephalosporins, cephamycins, monobactams and carbapenems ( ertapenem), although carbap ...
.
It is available for oral use.
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. ()
* 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 this name was rejected by the FDA.
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Clinical use
As of 8 September 2015, Faropenem has yet to receive marketing approval in the United States, and was submitted for consideration by the United States
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(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
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.
In India it is available as Farobact 200/300ER CIPLA.
References
External links
DrugBank website
{{CephalosporinAntiBiotics
Carbapenem antibiotics
Tetrahydrofurans