FDA Approves New Rx for Skin Infections

Orbactiv is third new antibacterial medication approved by FDA this year

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) It's been quite a year for new antibacterial medications. The US Food and Drug Administration (FDA) has just approved the third new medication in 2014 to treat certain skin infections.

The FDA has approved Orbactiv (oritavancin) to treat adults with acute bacterial skin and skin structure infections (ABSSSI). These infections include those caused by methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible Staphylococcus aureus (MSSA) as well as Enterococcus faecalis.

Orbactiv is the third antibacterial medication approved this year for use in the US to treat ABSSSI. Earlier this year, the FDA also approved Dalvance (dalbavancin) and Sivextro (tedizolid).

"Seek treatment if you have developed a skin infection."

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

According to E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsburg, Kentucky, "The FDA has been attempting to expedite approval of newer antimicrobials such as oritavancin due to an ever-increasing number of adverse outcomes attributed to ABSSSIs. In general, pharmaceutical companies have not placed a high emphasis on development of newer antibiotics, leaving infectious disease specialists scrambling at times to find effective treatment regimens for patients."

Orbactiv is marketed by The Medicines Company.

According to the company, ABSSSI leads to about 5.2 million hospitalizations in the US and Western Europe each year. Patients typically need to stay multiple days in the hospital while they receive intravenous (injected into the veins) treatment.

Orbactiv is one such intravenous medication. Its safety and effectiveness was tested in two clinical trials that included nearly 2,000 adults with ABSSSI. These adults received either Orbactiv or vancomycin (brand name Vancocin), currently the standard treatment for ABSSSI. The results showed that Orbactiv worked as well as vancomycin.

The most common side effects seen in these trials were headache, vomiting, diarrhea, and skin and soft tissue abscesses on the arms and legs.

"Until recently, vancomycin was the only viable option available to treat these serious gram-positive skin infections due to increasing resistance to other frontline antibiotics. Concern is that resistance to vancomycin has been on the rise, particularly for MRSA infections, so it is quite important that clinicians have other options to treat these serious outbreaks," Carter told dailyRx News.

Review Date: 
August 7, 2014
Last Updated:
August 11, 2014