FDA Approves DORIBAX for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections

RARITAN, N.J. -- The U.S. Food and Drug Administration (FDA) has approved DORIBAXTM (doripenem for injection) as a new treatment for complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis. DORIBAX has demonstrated activity against a wide range of Gram-positive and Gram-negative bacteria including Pseudomonas -- that cause these serious infections. 

DORIBAX belongs to a class of antibacterial agents called carbapenems, which are important for treating serious infections caused by Gram-positive and Gram-negative bacteria.

The approval of DORIBAX is based on results of clinical trials in complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).  In two multi-center, prospective, randomized, double-blind studies, DORIBAX was found to be effective and well tolerated for the treatment of complicated intra-abdominal infections. In another multi-center, randomized, double-blind study and an additional single-arm, multi-center study, DORIBAX was found to be effective and well tolerated for the treatment of complicated urinary tract infections.

DORIBAX was effective against major organisms that cause cIAI and cUTI, including E. coli, B. fragilis, viridans group streptococci, Proteus species, K. pneumoniae and Pseudomonas aeruginosa.

Pseudomonas aeruginosa, a Gram-negative bacterium with increasing multi-drug resistance, is one of the leading causes of hospital-acquired infections.  In general, there are few antibiotics available or in development to treat these life-threatening Gram-negative infections.

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

Approximately 2 million intra-abdominal procedures are performed in the U.S. each year. Complicated intra-abdominal infections are infections that extend beyond the hollow cavity of the abdomen into the peritoneal space and are a common cause of hospitalization following these procedures.

Urinary tract infections (UTIs) account for at least 40 percent of all hospital infections. Although many cases of UTI are uncomplicated, a significant proportion of UTIs are classified as complicated because of anatomical abnormalities in the urinary tract, which make clearance of bacteria more difficult, or cause kidney infection (pyelonephritis). Complicated UTIs can be caused by a broad range of bacteria, many of which are resistant to multiple antibiotics.

DORIBAX will be marketed to U.S. hospitals and other healthcare institutions by Ortho-McNeil, Inc. through its Institutional Franchise. The use of doripenem in the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia, is under regulatory review in the U.S., and the use of doripenem for complicated intra-abdominal infections, complicated urinary tract infections and nosocomial pneumonia, including ventilator-associated pneumonia, is under regulatory review in Europe. Doripenem is licensed from Shionogi & Co., Ltd., which launched the product in Japan in September 2005 under the name, FINIBAX.

Source: Ortho-McNeil, Inc.