FDA Approved Orbactiv to Treat Adults With Skin Infections

The FDA panel has approved a new antibacterial drug called Orbactiv to treat adults with skin infections.

In a latest announcement, the U.S. Food and Drug Administration gave a nod to Orbactiv (oritavacin) - a new antibacterial drug that is used to treat adults with acute bacterial skin and skin structure infections (ABSSSI) that is caused by certain susceptible bacteria including Staphylococcus aurerus, various Streptococcus species and Enterococcus faecalis.

This newly approved antibacterial drug is administered intravenously. This is the third new antibacterial drug that is approved by the FDA panel this year to treat ABSSI. Prior to this, Dalvance (dalbavancin) in May 2014 and Sivextra (tedizolid) in June 2014 got a nod from the FDA.

"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. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs."

Orbactiv was also given Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Incentives Now (GAIN) as it is an antibacterial or antifungal human drug that is intended to treat a serious or life-threatening infection.

As part of QIDP designation, Orbactiv was given a priority review that offers an expedited review of the drug's application. The safety and efficacy of the drug was evaluated via two clinical trials that included a total of 1,987 adults with ABSSI. The participants were randomly given Orbactiv or Vancomycin. They noticed that Orbactiv was more effective than vancomycin in treating ABSSSI.

The most common side effects identified during the clinical trials were headache, nausea, vomiting, formation of skin and soft tissue abscesses on arms and legs and diarrhea. The drug's label also carries a warning regarding interference with coagulation tests and interaction with warfarin, a drug that is used to prevent blood clots.

The drug is marketed by the Medicines Company based in Parsippany, N.J.