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news.The US Food and Drug Administration has said that it will not approve Replidyne and Forest Laboratories' antibiotic faropenem medoxomil unless further studies are carried out on the drug.
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Replidyne submitted a new drug application in December 2005 for four indications including acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections. The FDA has said that it requires trials for all four indications.
Replidyne and Forest have jointly developed the drug and have been partners since an agreement on February 13, 2006.
The new drug application was based on the results of 11 phase III clinical trials and a safety data base of more than 5,000 patients treated with faropenem.
Replidyne and Forest said they expected that a minimum of two years would be required for completion of the clinical studies.
The decision by the FDA is a setback for the companies however Replidyne pointed to the good safety profile of the drug. The companies also said that they believed recent public FDA deliberations over the need for placebo controlled studies for antibiotics were a factor in its decision. In its letter the FDA did not raise any safety concerns or chemistry, manufacturing or controls issues related to the product.
“We are disappointed that the FDA is requiring additional clinical trials,” said Kenneth Collins, CEO of Replidyne. “However, we believe that at the doses studied faropenem has a clearly demonstrated favorable safety profile.