Oritavancin (Orbactiv) has been approved by the FDA to treat adult patients with acute bacterial skin and skin structure infections caused by certain susceptible bacteria.
The lipoglycopeptide antibiotic is approved to treat Staphylococcus aureus — including methicillin-susceptible and methicillin-resistant strains — various Streptococcus species and Enterococcus faecalis.
Oritavancin is the third new antibacterial drug approved by the FDA this year to treat acute bacterial skin and skin structure infections (ABSSSI). The agency approved dalbavancin (Dalvance) in May 2014 and tedizolid (Sivextro) in June 2014.
“The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”
The safety and efficacy of oritavancin were evaluated in two clinical trials with 1,987 adult patients with ABSSSI. The patients were randomly assigned to receive oritavancin or vancomycin. Results demonstrated that oritavancin was as effective as vancomycin for the treatment of ABSSSI.
The most common side effects identified in the clinical trials were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs, and diarrhea. Oritavancin’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin, a drug used to prevent blood clots.