FDA approves injectable treatment for complicated UTIs

The FDA has approved injectable doripenem (Doribax) for the treatment of complicated urinary tract infections, including pyelonephritis. Doripenem has demonstrated activity against a wide range of gram-positive and gram-negative bacteria, including Pseudomonas, that cause these serious infections, research has shown.

Doripenem, which belongs to a class of antibacterial agents called carbapenems, was found to be effective and well tolerated in a multicenter, randomized, double-blind study and an additional single-arm, multicenter study. The agent was effective against major organisms that cause complicated UTIs, including E. coli, B. fragilis, viridans group streptococci, Proteus species, K. pneumoniae, and Pseudomonas aeruginosa.

“New agents are urgently needed to effectively treat gram-negative and gram-positive bacterial infections,” said Joseph Solomkin, MD, of the University of Cincinnati College of Medicine. “The introduction of doripenem is important for the treatment of these serious infections as fewer antibiotics appear to effectively eradicate many troublesome bacteria, such as Pseudomonas.”