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news.Trius Therapeutics has begun the second global Phase 3 pivotal trial in acute bacterial skin and skin structure infections (ABSSSI).
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The trial, TR701-113 will study the possibility of switching tedizolid phosphate as a once-daily intravenous (IV) infusion to once-daily oral therapy in ABSSSI patients.
The 113 study in collaboration with Bayer HealthCare will recruit patients in North and South America, Europe, South Africa and Asia.
The 113 study and the recently enrolled TR701-112 study will compare the efficacy and safety of once-daily administration of 200mg of tedizolid phosphate for 6 days with that of twice-daily administration of 600 milligrams of linezolid for 10 days.
Following the completion of the study, the company hopes to submit New Drug Application (NDA) to the FDA for potential approval of tedizolid phosphate for the treatment of ABSSSI.