Cubist's Sivextro Wins FDA Approval to Treat Skin Infections

The U.S. federal regulators gave the nod to a new antibacterial drug called Sivextro to treat skin infections in adults.

The U.S. Food and Drug Administration approved a new antibacterial drug called Sivextro (tedizolid phosphate) to treat adults with acute bacterial skin and skin structure infections  (ABSSSI) that is caused by certain bacteria that includes Staphylococcus aurerus (including methicillin-resistant stars (MRSA) and methicillin-susceptible strains), several Streptococcus species and Enterococcus faecalis.

The newly approved antibacterial drug is approved for both intravenous as well as oral use.  This is the second new antibacterial drug that has been sanctioned by the FDA in the past months to treat ABSSSI. 

Prior to this, Dalvance (dalbavancin) was approved by the FDA on May 23 to treat ABSSSI that is caused by Staphylococcus aureus and various Streptcoccus species.

"Today's approval provides physicians and patients with a new treatment option for serious skin infections," 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.

Sivextro is designated as a qualified infectious disease product (QIDP) as it treats serious or life-threatening infections.  The safety and efficacy of the new antibacterial drug was evaluated in two clinical trials that included 1,315 adults with ABSSSI. 

In the clinical trials the participants were randomly given either Sivextro or linezolid, another antibacterial drug that is used to treat ABSSSI. The researchers observed that Sivextro was significantly more effective than linezolid to treat ABSSSI.

Some of the common side effects noticed during the clinical trials were nausea, headache, diarrhea, vomiting and dizziness.

Sivextro is marketed by Cubist Pharmaceuticals.