Trius Therapeutics Obtains Special Protocol Assessment With FDA For Phase 3 Study Of Torezolid Phosphate

Trius Therapeutics, announced that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study for the oral dosage form of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI). The double-blind pivotal study will compare the efficacy and safety of once-daily oral administration of 200 milligrams of torezolid phosphate over six days of treatment to twice-daily oral administration of 600 milligrams of linezolid (Zyvox) for 10 days of treatment.............& more