TEDIZOLID RECEIVES QIDP DESIGNATION FROM FDA (Part II)
Tedizolid recently completed enrollment of its second ABSSSI Phase 3 trial, designated ESTABLISH 2, which examined the efficacy and safety of a six-day course of tedizolid administered once a day versus a 10-day course of linezolid (Zyvox®) administered twice a day in patients recruited across sites in North and South America, Europe, Australia, New Zealand and South Africa. For both tedizolid and linezolid, drug was initially administered as an intravenous (IV) infusion with the option to switch to oral therapy. In September of 2012, Trius presented detailed results of its ESTABLISH 1 trial, which tested the oral dosage form of tedizolid. The ESTABLISH 1 trial achieved all FDA and European Medicines Agency (EMA) primary and secondary efficacy outcomes and demonstrated significantly lower safety and tolerability events compared to linezolid.
At December 31, 2012, Trius estimates that it had cash, cash equivalents and investments totaling $66.0 million. This amount is preliminary, unaudited, subject to change upon completion of our year-end audit, and may differ from what will be reflected in our audited financial statements as of and for the year ended December 31, 2012. Additional information and disclosures would be required for a more complete understanding of our financial position and results of operations as of December 31, 2012.