The US Food and Drug Administration (FDA) approved Sivextro (tedizolid phosphate), a new antibacterial drug for the treatment of adults with acute bacterial skin and skin structure infections.
Given via intravenous or orally, the drug is effective against infections caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis.
Cubist Pharmaceuticals’ Sivextro is the second new antibacterial drug approved by the FDA in the past month to treat these types of infections. On May 23, the agency approved Dalvance (dalbavancin) with similar indications.
The application for Sivextro was designated as a qualified infectious disease product (QIDP) and received an expedited review. The drugs QIDP designation also qualifies it for an additional 5 years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.
According to the studies that led to the new antibiotic’s approval, Sivextro was as effective as linezolid for the treatment of these serious skin infections.
The most common side effects were nausea, headache, diarrhea, vomiting, and dizziness. The safety and efficacy of Sivextro have not been evaluated in patients with neutropenia, so alternative therapies should be considered for these individuals.