The Phase III pivotal study of TR701-112 is the first of two pivotal Phase II trials designed to support the filing of a NDA with the FDA as well as MAA with the EMA.
The 112 study tested the oral dosage form of tedizolid phosphate versus the comparator linezolid (Zyvox) in patients with acute bacterial skin and skin structure infections (ABSSSI).
The second Phase 3 trial of tedizolid phosphate in ABSSSI, designated TR701-113, for its intravenous (IV) to oral transition therapy was initiated by the company in September 2011.
The company expects to report top-line data of the study in early 2013.
The 113 study is the first clinical trial conducted in collaboration with Bayer HealthCare and will recruit patients in North and South America, Europe, Australia, New Zealand, and South Africa.