FDA approves MRSA drug tedizolid

The Food and Drug Administration has approved tedizolid phosphate (Sivextro, Cubist Pharmaceuticals) for the treatment of adult acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The drug is administered once daily for six days. The most commonly reported side effects in clinical studies were gastrointestinal events such as diarrhea, nausea and vomiting. Those who develop diarrhea after taking the drug should be evaluated for Clostridium difficile, which has been reported with the use of tedizolid and other systemic antibacterial agents.

Intravenous and oral formulations of the medication are available, enabling physicians to transition people from the injectable version to the pill. “The oral option…could reduce the need for costly hospitalization,” says Michael Bonney, CEO of Cubist.

Among the other bacterial infections for which tedizolid is approved are methicillin-susceptible [MSSA] isolates, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius and S. constellatus) and Enterococccus faecalis.

The FDA approved the drug June 20. Read about the approval here.

Topics: Clinical