By Emily Miller
Last week, the U.S. Food and Drug Administration approved Orbactiv – also known as oritavancin – to help treat various types of skin infections. The new antibacterial drug is geared to treat adults and is marketed by the Medicines Company, based in New Jersey.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus, various Streptococcus species and Entercoccus faecalis.
It is administered intravenously, which means through or within a vein. By doing this the antibacterial drug can work deep beneath the surface to treat the infection.
Orbactiv is third new antibacterial drug this year to receive approval by the FDA to treat ABSSSI. The agency approved Dalvance in May 2014 and Sivextro is 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, M.D., M.P.H, director of the office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research in a press release.
Orbactiv is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. It was granted this designation, as it is an antibacterial or antifungal drug intended to treat a serious or life-threatening infection.
This designation also qualifies it for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug, and Cosmetic Act.
“However, more work is needed to this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs,” said Cox.
According to the FDA, the most common side effects were headaches, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs, and diarrhea.
Orbactiv’s warning label also includes a warning regarding interference with coagulation tests and interaction with warfarin, a drug used to prevent blood clots.
It is advisable to consult with your regular physician prior to taking Orbactiv, as the drug may not be suitable with your needs or not covered under your health insurance.
