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news.Oscient Pharmaceuticals has completed enrollment in a phase IV post-marketing trial for its antibiotic Factive indicated for the treatment of respiratory infections.
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A commitment to complete post-marketing trials has become a condition of approval for many drugs and this trial was expected to take three to four years to complete. Patient enrollment was completed nearly one year ahead of schedule, which allows for the submission of the study report to the FDA earlier than planned.
“By meeting our commitment to the FDA ahead of schedule, we reduce the total expense of the study and, following submission, our clinical development expenditures will decrease,” stated Steven Rauscher, president and CEO of Oscient Pharmaceuticals.
The study was designed to examine the safety of Factive in treating community-acquired pneumonia of mild to moderate severity versus clarithromycin and in treating acute bacterial exacerbations of chronic bronchitis versus amoxicillin/clavulanate in the community.