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news.Replidyne will have to conduct four extra phase III studies on its oral community antibiotic faropenem if it is to be approved, the FDA has said.
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In October 2006, the FDA issued a non-approvable letter to Replidyne for faropenem and the FDA recommended further clinical studies for the drug. The FDA did not raise any safety concerns or chemistry, manufacturing or controls issues related to faropenem.
The FDA said the trials will need to be conducted in three adult respiratory indications including acute bacterial sinusitis (ABS), community acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis (AECB).
According to this plan, Replidyne could conduct two active-controlled, non-inferiority studies using faropenem in patients with CAP, as well as one placebo-controlled superiority trial each in patients with ABS and AECB to submit for approval of these three indications.
Replidyne and the FDA have agreed that future clinical trials of faropenem will be conducted using a 600mg dose, administered twice daily. The FDA has further indicated that an acceptable safety database needed for review at this dose is approximately 1500 patients, assuming no safety signals emerge during the studies.
New treatment options for community antibiotics are necessary as, according to the Centers for Disease Control and Prevention, nearly all significant bacterial infections in the world are becoming resistant to the most commonly prescribed antibiotic treatments.