New Antibiotic Tedizolid (Sivextro) Approved by FDA

Disclosures

June 20, 2014

Hustling to overcome antibiotic resistance, the US Food and Drug Administration (FDA) today approved a new antibiotic for skin infections after having approved another one just 5 weeks ago, the agency announced today.

The latest antibiotic is tedizolid phosphate (Sivextro, Cubist Pharmaceuticals). It is indicated for adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria such as several Streptococcus species and the notorious methicillin-resistant Staphylococcus aureus (MRSA).

On May 23, the FDA approved an antibiotic called dalbavancin (Dalvance, Durata Therapeutics) that treats the same kinds of infections.

The World Health Organization and other groups call antibiotic resistance a major threat to public health. US lawmakers have pushed for the development of new antibiotics to thwart the superbugs.

The FDA determined that tedizolid phosphate was safe and effective based on 2 clinical trials involving 1315 adults with ABSSSI. Some received tedizolid while others received the antibiotic linezolid. Tedizolid proved just as effective in treating the skin infection as linezolid.

Nausea, headache, diarrhea, vomiting, and dizziness were the most common side effects to surface in the clinical trials. Clinicians should consider alternative therapies for patients with both ABSSSI and neutropenia because the safety and effectiveness of tedizolid phosphate in this population was not studied, according to the FDA.

Sivextro is administered once daily for 6 days, and is available in intravenous and oral formulations, according to a company release.

More information on today's drug approval is available on the FDA Web site.

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