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The European Medical Agency has approved the use of two new antibacterial drugs for skin and soft tissue infections

The Committee for Medicinal Products for Human Use (CHMP) of the European Medical Agency (EMA) recommended in January 2015 the approval of two new antibacterial drugs for the treatment of adult patients with acute bacterial skin and soft tissue infections - oritavancin (Orbactiv, The Medicines Co) and tedisolide phosphate (Sivextro, cubist Pharmaceutical products).

The advantage of oritavancin is the possibility of using it at a dose of 400 mg once intravenously - this dosage regimen is equivalent to the standard duration of the course with another antibiotic.

In two identical design clinical trials (SOLO 1 and SOLO 2), oritavancin demonstrated efficacy equivalent to vancomycin according to the criteria of "early clinical response after 48 to 72 hours" (to reduce the spread or decrease the size of the main focus of infection) and "frequency of clinical recovery".

The most common adverse events associated with the use of the new antibiotic glycopeptide, oritavancin, were nausea, hypersensitivity reactions, injection site irritants, and headache.

Tedizolid phosphate is a new drug from the oxazolidinone group, available as tablets and infusions.

EMA approval was obtained based on 2 phase III studies in which patients received tedizolide once daily for 6 days or linezolid (Zivox, Pfizer) 2 times daily for 10 days. In both studies, tedizolid has shown clinical and microbiological efficacy equivalent to linezolid in acute bacterial infections of the skin and soft tissues, including cases caused by methicillin-sensitive and methicillin-resistant Staphylococcus aureus (MSSA and MRSA). The activity of tedizolid against strains of Staphylococcus aureus resistant to linezolid should be noted.

The most common adverse events associated with the use of tedizolid have been nausea, headache, diarrhea and vomiting.

Earlier, the United States Food and Drug Administration (FDA) approved oritavancin in August 2014 and earlier in June 2014 for the treatment of adult patients with acute bacterial skin and soft tissue infections caused by certain drugs susceptible to microorganisms such as S. aureus (including strains sensitive to methicillin and resistant to methicillin), various streptococci and Enterococcus faecalis.

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