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It's time for the U.S. Food and Drug Administration to decide on the type of study design it finds acceptable for the approval of new antibiotics, urges a Leading Edge editorial in the April issue of The Lancet Infectious Diseases.
WEDNESDAY, March 19 (HealthDay News) -- It's time for the U.S. Food and Drug Administration to decide on the type of study design it finds acceptable for the approval of new antibiotics, urges a Leading Edge editorial in the April issue of The Lancet Infectious Diseases.
Although the agency has always allowed non-inferiority trials for new antibiotics, in which a new drug must not be less effective than the existing comparator medication, it is now requesting superiority trials, in which the drug under investigation must perform better than an active drug or a placebo, according to the authors of the article.
In October 2007, the FDA proposed in draft guidance that trial sponsors consider superiority designs for drugs used for acute bacterial sinusitis, otitis media and exacerbation of chronic bronchitis. It is now contemplating requesting superiority trials when the indication for the drug is community acquired pneumonia. This change may be due to the withdrawal of approval for telithromycin for acute bacterial sinusitis and exacerbation of chronic bronchitis.
"The FDA needs urgently to issue definitive guidelines on the design of trials it deems acceptable for approving new antibiotics. No one design will fit all circumstances. For certain indications, the pharmaceutical industry will likely have to accept placebo-controlled, superiority designs with endpoints such as time to resolution of symptoms, as it did in the 1990s with trials of neuraminidase inhibitors for uncomplicated influenza. Such endpoints should be phased in alongside ones already considered standard (e.g., clinical cure)," the authors write.
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