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FDA Approves Ortho-McNeil Pharmaceutical, Inc.'s LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis


9/17/2007 6:57:52 AM

RARITAN, N.J., Sept. 17 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved use of the five-day, once-daily regimen of LEVAQUIN(R) (levofloxacin) 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). (1)

This latest approval is based on results of a double-blind, randomized clinical trial involving 1,109 patients with either cUTI or AP which assessed the efficacy and safety of LEVAQUIN (750 mg/once daily/five days) versus ciprofloxacin (Cipro(R)*) (400/500 mg/twice daily/10 days). Microbiologic eradication and clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both LEVAQUIN (750 mg/once daily/five days) and ciprofloxacin (400/500 mg/twice daily/10 days) groups.

"The availability of this high-dose, short-course antibiotic regimen provides clinicians with an important tool in the management of cUTI and AP," said Richard David, MD, FACS, Associate Clinical Professor of Urology, David Geffen School of Medicine at UCLA. "Patients do not always finish a longer course of antibiotics. A shorter course of antibiotic offers patients the convenience of five day, once-daily therapy."

Each year, urinary tract infections account for more than eight million physician visits in the U.S. They occur in the kidneys, ureters, bladder or the urethra and often are recurrent, resulting in treatment with several courses of antibiotics. Complicated UTIs occur nearly as frequently in men as in women and often occur in people who are susceptible to bacterial infections because of a weakened immune system. Complicated UTIs also may be caused by structural or functional difficulties that interfere with the flow of urine, such as kidney stones.

Pyelonephritis is an infection of one or both kidneys caused by bacteria. It is estimated that more than 250,000 Americans suffer from AP every year, with 10 to 30 percent of cases resulting in hospitalization.

Ortho-McNeil, Inc., along with Johnson & Johnson Pharmaceutical Research & Development, L.L.C., conducted the clinical trial. LEVAQUIN is available in 250 mg, 500 mg and 750 mg doses in both I.V. and oral formulations. The safety profile of LEVAQUIN is similar across doses. LEVAQUIN is marketed to healthcare providers by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil, Inc.

About LEVAQUIN(R)

Since its U.S. introduction in 1996, LEVAQUIN has gained widespread use in the treatment of adults for a variety of bacterial infections caused by susceptible pathogens [1], including: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections (mild to moderate), chronic bacterial prostatitis, complicated and uncomplicated urinary tract infections (mild to moderate) (10 day regimen), complicated urinary tract infections (5 day regimen), acute pyelonephritis, and inhalational anthrax (post-exposure).

Important Safety Information

The most common adverse drug reactions (> or = 3%) in US clinical trials were nausea, headache, diarrhea, insomnia, constipation, and dizziness.

Safety and efficacy in pregnant women and nursing mothers have not been established. Levofloxacin is not indicated for pediatric patients (<18 years of age). Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin or other quinolone antibacterials. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions and some of unknown etiology, have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions may include effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure, and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. Discontinue levofloxacin at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity.

Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin, during and after therapy. This risk is increased in patients over 65 years old, and is further increased with concomitant corticosteroid therapy. Discontinue in patients experiencing pain, inflammation, or tendon rupture.

Central nervous system effects, including convulsions, confusion, anxiety, depression, and insomnia, may occur after the first dose. As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system disorders that may predispose them to seizures or lower the seizure threshold.

Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including levofloxacin. If diarrhea occurs, evaluate for CDAD and treat appropriately.

Rare cases of peripheral neuropathy have been reported in patients receiving quinolones, including levofloxacin. Discontinue if symptoms of neuropathy occur to prevent the development of an irreversible condition.

Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. Levofloxacin should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx(R)** (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within 2 hours before or after levofloxacin administration.

For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full Prescribing Information at www.levaquin.com

About Ortho-McNeil, Inc.

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. PriCara, Unit of Ortho-McNeil, Inc., markets products specifically in the areas of gastrointestinal and infectious diseases and pain management. For more information, visit www.ortho-mcneil.com or www.pricara.com

* Cipro is a registered trademark of Bayer HealthCare ** Videx is a registered trademark of Bristol-Myers Squibb Company (1) Please see the full Prescribing Information for a complete list of indicated pathogens and recommended dosages and treatment regimens at www.levaquin.com

Ortho-McNeil, Inc.

CONTACT: Media, Amy Firsching, +1-908-218-7583, Samina Bari,+1-908-218-6483, IR Contacts, Stan Panasewicz, +1-732-524-2524, LesleyFishman, +1-732-524-3922, or Louise Mehrotra, +1-732-524-6491


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