Durata Therapeutics has received a Special Protocol Agreement (SPA) from the Food and Drug Administration 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.

“If successful, DALVANCE would provide a single-dose treatment alternative for patients with community acquired pneumonia effective against the most common bacterial respiratory pathogens, including those resistant to other classes of antibiotics,” said Michael Dunne, MD, Durata’s chief medical officer.