Trius Therapeutics Obtains Special Protocol Assessment With FDA for Second Phase 3 Study of Torezolid Phosphate
Study Will Examine Efficacy and Safety of IV and Oral Dosing of Torezolid Phosphate in Patients With ABSSSI
Press Release Source: Trius Therapeutics, Inc. On Friday August 5, 2011, 6:00 am EDT
SAN DIEGO, Aug. 5, 2011 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq: TSRX - News) announced today 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 second planned Phase 3 study for the intravenous and oral dosage forms of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI). This double-blind pivotal study will compare the efficacy and safety of once-daily administration of 200 milligrams of torezolid phosphate for six days of treatment to twice-daily administration of 600 milligrams of linezolid (Zyvox) for 10 days of treatment. All patients will be initiated on the intravenous dosage (IV) form for a minimum of one day's treatment and will be transitioned to the oral dosage form at the discretion of the clinical investigator. As with the first on-going Phase 3 study testing the oral dosage form, the primary efficacy endpoint of the IV to oral transition study will be the cessation of infected lesion spread and absence of fever at 48 to 72 hours following initiation of treatment. 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. Provided non-inferiority is met, an assessment of superiority of torezolid phosphate to linezolid with respect to the primary efficacy endpoint will also be made. Trius expects to start this second pivotal study in the fourth quarter of this year.
