Ortho-McNeil Says Gets FDA Approval for Doribax
RARITAN, N.J., Oct. 15 -- The U.S. Food and Drug Administration (FDA) has approved DORIBAX(TM) (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(1) and Gram-negative(2) 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 (nosocomial) 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, M.D., Professor of Surgery and Director of Research, 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 two 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% 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.
DORIBAX is indicated as a single agent for the treatment of: complicated intra-abdominal infections caused by susceptible strains of E. coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S. constellatus or P. micros and for the treatment of complicated urinary tract infections, including pyelonephritis, caused by susceptible strains of E. coli, including cases with concurrent bacteremia, K. pneumoniae, P. mirabilis, P. aeruginosa, or A. baumannii.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX and other antibacterial drugs, DORIBAX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
IMPORTANT SAFETY INFORMATION
DORIBAX is contraindicated in patients with known serious hypersensitivity to doripenem or other carbapenems or in patients who have demonstrated anaphylactic reactions to beta-lactams.
Serious and occasionally fatal hypersensitivity (anaphylactic) and serious skin reactions have been reported in patients receiving beta-lactam antibiotics. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. If an allergic reaction to DORIBAX occurs, discontinue the drug. Serious acute anaphylactic reactions require emergency treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
Carbapenems may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations cannot be maintained in the therapeutic range or seizures occur.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
When doripenem has been used investigationally via inhalation, pneumonitis has occurred. DORIBAX should not be administered by this route.
Safety and effectiveness in pediatric patients have not been established.
The most common adverse reactions (greater than or equal to 5%) observed in clinical trials were headache, nausea, diarrhea, rash and phlebitis.
Ortho-McNeil, Inc., is committed to providing innovative, high-quality prescription medicines, education and resources for patients, healthcare providers, and other members of the healthcare community in primary care, specialty and hospital settings. Headquartered in Raritan, N.J., the company markets products for infectious diseases, gastrointestinal disorders, pain management, women's healthcare and urology. For more information, visit www.ortho-mcneil.com.
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