FDA PANEL REJECTS OSCIENT'S FACTIVE SNDA FOR SINUSITIS

Oscient Pharmaceuticals has announced the results of a meeting of the FDA's Anti-Infective Drugs Advisory Committee. The panel voted on topics related to the company's supplemental new drug application (sNDA) seeking approval for the use of Factive (gemifloxacin mesylate) tablets in treating acute bacterial sinusitis.

The panel voted on two topics related to the sNDA. For the first question, the panel voted 10-4 that the data from the non-inferiority clinical trials of Factive were not sufficient to demonstrate efficacy in the treatment of acute bacterial sinusitis. For the question of whether the safety and effectiveness data demonstrate an acceptable risk/benefit profile for the five-day treatment of patients with acute bacterial sinusitis, the panel voted 11-2 that the data did not support the approval of Factive for the treatment of acute bacterial sinusitis.

Oscient's sNDA contains data from five Phase III trials involving more than 1,800 patients receiving Factive and 500 patients receiving a comparator. Of the 1,800 patients in the studies, more than 1,100 received Factive for five days of treatment. The filing also includes safety data gathered from the postmarketing surveillance of Factive since the drug's launch in 2004 for the treatment of mild-to-moderate community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. An FDA decision on this sNDA is expected by Dec. 15. Although the FDA is not obligated to follow the recommendations of the advisory committee, it typically does, according to the company.