Sivextro approved to treat skin infections

June 23, 2014

FDA has approved the new antibacterial drug tedizolid phosphate (Sivextro, Cubist Pharmaceuticals) to treat adults with skin infections.

FDA has approved the new antibacterial drug tedizolid phosphate (Sivextro, Cubist Pharmaceuticals) to treat adults with skin infections.

Sivextro can be administered intravenously or orally, and is approved for patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis.

“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.

Last month, FDA approved dalbavancin (Dalvance, Durata Therapeutics) for patients with ABSSSI caused by S. aureus and various Streptococcus species.

According to FDA, Sivextro was evaluated in two clinical trials with 1,315 adults with ABSSSI. Trial participants either received Sivextro or linezolid, another antibacterial drug used to treat ABSSSI.

Sivextro was shown to be as effective as linezolid for the treatment of ABSSSI. The most common side effects associated with Sivextro were nausea, headache, diarrhea, vomiting, and dizziness. Sivextro was not evaluated in patients with decreased levels of white blood cells (neutropenia), so FDA said alternative therapies should be considered.