Oscient Pharmaceuticals submits FDA application for new indications for Factive

By Angela McDaniels

Seattle, Nov. 21 - Oscient Pharmaceuticals said it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking approval for the use of Factive (gemifloxacin mesylate) 320 mg once-daily tablets for the five-day treatment of acute bacterial sinusitis and the five-day treatment of mild to moderate community-acquired pneumonia.

Factive is currently approved by the FDA for the five-day treatment of acute bacterial exacerbations of chronic bronchitis and the seven-day treatment of mild to moderate community-acquired pneumonia, the company said.

"Obtaining five-day treatment indications for these conditions would create a unique marketing position for Factive and solidify the base upon which we will built Factive into a leading brand," president and chief executive officer Steven M. Rauscher said in a company news release.

"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. Currently, no fluoroquinolone is approved for five-day treatment of all three major respiratory tract infections: acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia."

An estimated 20 million cases of acute bacterial sinusitis occur annually in the United States, the company said, and sinusitis accounts for about 20% of all adult antibiotic prescriptions resulting in a yearly cost of more than $3.5 billion.

Additionally, community-acquired pneumonia is a common and serious illness in the United States with 3 to 4 million cases per year, resulting in approximately 1 million hospitalizations and 40,000 deaths annually.

Oscient is a biopharmaceutical company based in Waltham, Mass., that develops therapeutics to address unmet medical needs.

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