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New Drug Application Submitted for Investigational Antibiotic Doripenem

RARITAN, N.J., Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD) announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for doripenem, an investigational carbapenem antibiotic for the treatment of nosocomial pneumonia, a pneumonia that is acquired in a hospital or other healthcare setting.

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(1) and Gram-positive(2) 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.


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