Faropenem

Faropenem is an orally-active beta-lactam antibiotic belonging to the penem group. It is the first orally-active penem antibiotic. 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 (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)(PubChem 6918218)

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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

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.