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news.Oscient Pharmaceuticals has submitted a supplemental new drug application to the FDA seeking approval for the use of Factive tablets for five-day treatment regimens of acute bacterial sinusitis and mild to moderate community-acquired pneumonia.
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Factive is currently approved by the FDA for the five-day treatment of acute bacterial exacerbations of chronic bronchitis and in a seven-day treatment regimen for mild to moderate community-acquired pneumonia.
“Obtaining five-day treatment indications for these conditions would create a unique marketing position for Factive,” stated Steven Rauscher, president and CEO of Oscient. “Moving to a five-day course of therapy for all of the indications for Factive would enhance its position as a valuable option for physicians treating difficult respiratory tract infections.”
The supplemental new drug application (sNDA) for the five-day treatment of acute bacterial sinusitis contains efficacy and safety data from five phase III trials involving more than 1,800 patients receiving Factive and 500 patients receiving a comparator (trovafloxacin or cefuroxime).
The submission for the five-day treatment of community-acquired pneumonia contains data from a successful phase III trial completed this year comparing a five-day and seven-day treatment with Factive 320mg once-daily for the condition in 510 patients.