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US FDA issues guidelines for developing drugs for acute bacterial sinusitis

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The US Food and Drug Administration (FDA) has issued guidelines for the pharmaceutical  industry for developing antimicrobials for the treatment of acute bacterial sinusitis (ABS). The FDA stated that any new drug being studied for ABS should have documenting in-vitro antibacterial activity against the most commonly pathogens associated with ABS. These include  Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Even though animal models of ABS has been developed, particularly for S. pneumoniae infection, they cannot substitute for clinical trials in patients that must be conducted to evaluate drug safety and efficacy. The FDA recommend that two adequate and well-controlled human trials establishing safety and efficacy be conducted for that indication.  However, a single trial for an ABS indication may be appropriate if there is data from other clinical trials demonstrating effectiveness in other respiratory tract diseases s