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Trius Gets SPA From FDA For Torezolid Phosphate Phase 3 Study

Trius Therapeutics has reached agreement with the 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 is expected to compare the efficacy and safety of once-daily oral administration of 200 mg of Torezolid Phosphate over six days of treatment to twice-daily oral administration of 600 mg of Linezolid (Zyvox) for 10 days of treatment.

Trius Therapeutics said that the primary efficacy endpoint will be the cessation of spread of infected lesions and absence of fever at 48 to 72 hours following initiation of treatment.

Whereas, the secondary endpoints will include, among other things, sustained clinical response at the end of therapy visit, and the investigator’s assessment of clinical response at all visits and clinical success at the post treatment evaluation visit.

Trius Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialiSation of innovative antibiotics for serious, life-threatening infections.