J&J PRESENTS DATA ON DORIPENEM TO TREAT PSEUDOMONAS

Johnson & Johnson (J&J) Pharmaceutical Research and Development has announced that doripenem, an investigational carbapenem antibiotic in Phase III trials, achieved a high clinical cure rate of 83 percent in patients with intra-abdominal infections. Doripenem also was active against a wide range of Gram-positive and Gram-negative bacteria that cause serious hospital infections -- including Pseudomonas.

Pseudomonas aeruginosa, a Gram-negative bacterium with increasing multidrug resistance, is one of the leading causes of nosocomial (hospital-acquired) infections for which treatment options are limited. In general, there are few antibiotics available and in development to treat these life-threatening Gram-negative infections.

Data from the Phase III clinical program showed that doripenem was active against major bacteria that cause complicated intra-abdominal infections, including E. coli, B. fragilis, Viridans Group streptococci and Pseudomonas aeruginosa. The primary objective of the study was to evaluate doripenem's safety and efficacy in the treatment of complicated intra-abdominal infections by comparing doripenem (500 mg IV q8h) to meropenem (1 gram IV q8h). In the microbiologically evaluable population, favorable clinical cure rates were achieved with 83.3 percent for doripenem and 83.0 percent for meropenem.

Additionally, data from a global surveillance study showed doripenem had greater in vitro activity compared with commonly used antimicrobial therapies against Pseudomonas aeruginosa, Pseudomonas spp. and other Gram-negative organisms.