The Food and Drug Administration has approved the injectable antibiotic oritavancin (Orbactiv) to treat adults with acute bacterial skin and skin structure infections that might be caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.
Oritavancin, which is manufactured and sold by The Medicines Company of Parsippany, N.J., is given in a single 3-hour infusion, after which the treatment regimen is considered complete.
Oritavancin is the third new antibacterial drug approved by the FDA in 2014 to treat acute bacterial skin and skin structure infections (ABSSSIs). The agency approved dalbavancin (Dalvance) in May and tedizolid (Sivextro) in June.
"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 Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs," he added.
Like dalbavancin and tedizolid, oritavancin was given priority review by the agency because it is intended to treat a serious or life-threatening condition. All three drugs also qualify for an additional 5 years of marketing exclusivity.
In a statement issued by The Medicines Company, several clinicians said that they welcomed the addition of oritavancin to their treatment arsenal. "With a single-dose treatment regimen, Orbactiv may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections," said Dr. G. Ralph Corey, professor of medicine and infectious diseases at Duke University, Durham, N.C.
"The growing challenge of antibiotic resistance in the U.S. has had a significant impact on the clinical management decisions in the emergency department," said Dr. Charles Pollack, professor of emergency medicine at the University of Pennsylvania, Philadelphia. A single, once-only IV therapy such as Orbactiv offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by gram-positive bacteria likely due to MRSA [methicillin-resistant Staphylococcus aureus]."
The FDA based its approval on the results of the SOLO I and SOLO II clinical studies. The randomized, double-blind, multicenter trials compared a single 1,200-mg IV dose to 7-10 days of twice-daily vancomycin (1 g or 15 mg/kg) in 1,987 patients. The trials also included a subset of 405 patients with documented MRSA. Oritavancin was equivalent to vancomycin in these trials.
The most common side effects were headache, nausea, vomiting, diarrhea, and the formation of skin and soft tissue abscesses on arms and legs, according to the FDA. The drug’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin.
Oritavancin also is under review in Europe for the treatment of complicated skin and soft tissue infections.
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