Durata: FDA Grants Special Protocol Agreement For DALVANCE Phase 3 Study

(RTTNews) - Durata Therapeutics (DRTX) announced that the company has received a Special Protocol Agreement (SPA) from the FDA on the design of its Phase 3 study of DALVANCE (dalbavancin) for injection using a 1500 mg single dose for the treatment of patients with community-acquired pneumonia requiring intravenous therapy.

DALVANCE is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. The study is designed to compare a 1500 mg single IV dose of dalbavancin with linezolid; patients randomized to linezolid can switch to oral therapy after an initial period of IV treatment.