The FDA has approved a third new antibacterial drug, Orbactiv (oritavancin), this year to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously. The other two drugs, Dalvance (dalbavancin) and Sivextro (tedizolid) were approved this past May and June respectively.
All three have been designated as a “Qualified Infectious Disease Product (QIDP)” under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, because of their use for treating serious or life-threatening deep tissue infections such as festering ulcers, burns, and major abscesses or a significant underlying disease state that complicates the response to treatment. In addition, “superficial infections” or abscesses in areas such as the rectum, where the risk of anaerobic or Gram-negative pathogen involvement is higher, are considered complicated infections and are often associated with diseases such as diabetes.
According to the federal government, more than 5 million people are hospitalized due to ABSSSI both in the US and western Europe annually.
“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,” stated Edward Cox, M.D., M.P.H, 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 most common side effects reported during the clinical trials involving nearly 2,000 adult patients were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhea. Orbactiv’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin, a drug used to prevent blood clots.