FDA Approves Third Drug To Treat Skin Infections

The FDA approved oritavancin (Orbactiv), an antibacterial drug to treat adults with acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus (including methicillin-susceptible and methicililin-resistant strains), various Streptococcus species, and Enterococcus faecalis. This is the third drug the FDA approved this year to treat ABSSSI.

Administered intravenously, the drug was tested in 2 clinical trials of 1987 adults with ABSSSI. Participants were randomly assigned oritavancin or vancomycin; results showed that both were equally effective in treating ABSSSI.
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The most common side effects include headache, nausea, vomiting, formation of skin and soft tissue abscesses on arms and legs, and diarrhea.

Orbactiv also carries a warning on the drug’s interference with coagulation tests and interaction with warfarin.

Reference:

FDA. FDA approves Orbactiv to treat skin infections [press release]. August 6, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm408475.htm. Accessed August 8, 2014.