ARTICLE | Clinical News

Dalbavancin: SPA received

November 3, 2014 8:00 AM UTC

Durata said it received an SPA from FDA for a Phase III trial to compare a single dose of 1,500 mg IV Dalvance plus a single dose of IV azithromycin vs. linezolid plus azithromycin in patients requiring IV therapy. The company expects to start the trial in late 2014 or early 2015. Patients in the linezolid arm can switch to oral therapy after an initial period of IV treatment.

Durata markets Dalvance in the U.S. as to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin is under review in the EU to treat complicated skin and soft tissue infections (cSSTIs) caused by susceptible Gram-positive microorganisms. Durata expects a decision in 1H15. Pfizer Inc. (NYSE:PFE, New York, N.Y) markets Zyvox linezolid. ...