Doripenem

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Doripenem is an ultra-broad spectrum injectable antibiotic. It is a beta-lactam and belongs to the subgroup carbapenem. It was launched by Shionogi Co. of Japan under the brand name "Finibax" in 2005. It is particularly active against Pseudomonas aeruginosa.

According to the Centers for Disease Control and Prevention (CDC), two million Americans develop hospital-acquired infections each year, and approximately 90,000 die as a result. Approximately 70 percent of these infections are resistant to at least one antibiotic. Pneumonia is the second, most-common, hospital-acquired infection in the United States and is associated with substantial morbidity and mortality.

Doripenem belongs to a class of antibacterial agents called carbapenems, which are useful in treating life-threatening infections caused by Gram-negative and Gram-positive bacteria. The data supporting the NDA showed doripenem was an effective treatment for hospital-acquired pneumonia. The data also demonstrated the effectiveness of doripenem against infections caused by Gram-negative bacteria, such as Pseudomonas aeruginosa and Enterobacteriaceae, including strains of these bacteria that are resistant to other therapies.

Pseudomonas aeruginosa is one of the leading causes of hospital-acquired infections and, because of increasing multi-drug resistance, treatment options are limited. In general, there are few antibiotics available or currently in development to treat the resistant infections - which can be potentially life-threatening - associated with these Gram-negative bacteria.

In clinical trials, doripenem was well-tolerated. The most common treatment-emergent adverse events seen were diarrhea, nausea, constipation, urinary tract infection and decubitus ulcer, commonly known as a bedsore.

The nosocomial pneumonia indication for doripenem had been granted "fast-track" status by the FDA. Pending regulatory approval, doripenem will be marketed in the United States by Ortho-McNeil, Inc. Doripenem is licensed from Shionogi & Co., Ltd., which launched the product in Japan in September 2005.