Dalbavancin, an antibacterial treatment for patients with complicated skin and soft tissue infections


Dalbavancin ( Xydalba ) is a antibacterial treatment for patients with complicated skin and soft tissue infections ( cSSTI ) caused by susceptible Gram-positive microorganisms, including Staphylococcus aureus ( including methicillin-resistant strains ) and Streptococcus pyogenes, as well as certain other streptococcal species.

The CHMP ( Committee for Medicinal Products for Human Use ) adopted a positive opinion, based on results from the two phase 3 trials, DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study ( VER001-9 ).
In the DISCOVER trials, cSSTI was defined as cellulitis, wound infection, or major cutaneous abscess with an associated area of surface erythema measuring at least 75 cm2 accompanied by at least two other local signs of infection and at least one of the following systemic signs of infection: fever, leukocytosis, or increased immature neutrophils.

Dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides.
When compared to Vancomycin, Dalbavancin has a longer half-life resulting in a duration of antibacterial activity of 5-7 days per dose.
Dalbavancin is the first drug for cSSTI requiring only two once-weekly 30-minute intravenous doses ( 1000 mg on day 1 and 500 mg on day 8 ). This may shorten the length of stay for patients who are hospitalized and, for appropriate patients, enable therapy in an outpatient setting eliminating the hospital admission altogether.
Ultimately, this may lower the overall cost of care for these patients. ( Xagena )

Source: Durata Therapeutics, 2014

XagenaMedicine_2014