Faropenem
Encyclopedia
Faropenem is an orally-active beta-lactam antibiotic
Beta-lactam antibiotic
β-Lactam antibiotics are a broad class of antibiotics, consisting of all antibiotic agents that contains a β-lactam nucleus in its molecular structure. This includes penicillin derivatives , cephalosporins , monobactams, and carbapenems...

 belonging to the penem
Penem
A penem is a type of unsaturated β-lactam.An example is faropenem.Penems are similar in structure to carbapenems. However, where penems have a sulfur, carbapenems have another carbon....

 group.

It is resistant to some forms of extended-spectrum beta-lactamase
Beta-lactamase
Beta-lactamases are enzymes produced by some bacteria and are responsible for their resistance to beta-lactam antibiotics like penicillins, cephamycins, and carbapenems . These antibiotics have a common element in their molecular structure: a four-atom ring known as a beta-lactam...

.

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.

  • 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)


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
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

(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.

External links

The source of this article is wikipedia, the free encyclopedia.  The text of this article is licensed under the GFDL.
 
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