FDA Approves Sivextro To Treat Skin Infections

Sivextro has been approved by the U.S Food and Drug Administration (FDA) to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI).

According to the FDA, Sivextro is the second new antibacterial drug to be approved to treat ABSSSI—skin infections caused by bacteria like Staphylococcus aureus (including Methicillin-resistant Staphylococcus aureus), Enterococcus faecalis, and several Streptococcus species—this past month. In May, the FDA approved Dalbavancin (Dalvance) for ABSSSI treatment.

Researchers evaluated Sivextro in 2 clinical trials that included 1315 adults suffering from ABSSSI. The patients were administered Sivextro or linezolid (another antibacterial drug) at random.
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Results demonstrated that Sivextro (tedizolid phosphate) was as safe and effective in the treatment of ABSSSI as linezolid.

Headache, nausea, diarrhea, vomiting, and dizziness were identified as the most common side effects during the clinical trials.

“Today’s approval provides physicians and patients with a new treatment option for serious skin infections,” said Edward Cox, MD, MPH, director of the office of antimicrobial products in the FDA’s center for drug evaluation and research.

The new antibacterial drug is prescribed for oral or intravenous use.

-Michelle Canales

Reference:

The U.S. Food and Drug Administration. FDA approves Sivextro to treat skin infections [press release]. June 20, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402174.htm. Accessed June 23, 2014.