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| |  FDA Approves New Indication for Avelox (moxifloxacin HCl) for Treatment of Complicated Intra-Abdominal Infections Once-Daily Avelox is Only Fluoroquinolone Approved for Monotherapy in Complicated Intra-abdominal Infections KENILWORTH, NJ -- November 30, 2005 -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved the once-daily, broad-spectrum antibiotic Avelox(R) (moxifloxacin HCl) for a new use -- the treatment of complicated intra-abdominal infections (cIAI) in adults. Avelox is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication. The FDA approval to treat cIAI is the sixth indication for Avelox. Avelox, available in tablet and intravenous (I.V.) formulations, was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering-Plough. Intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that cause bacteria to leak from the gastrointestinal tract into adjacent tissue. There are approximately 3.5 million cases in the United States each year, with many patients contracting the infection secondary to appendicitis.(1) "The FDA approval of Avelox to treat complicated intra-abdominal infections is welcome news, providing doctors with an effective treatment option for their patients, and giving patients convenient once-daily dosing and an easy transition from I.V. to oral therapy when they leave the hospital," said Joseph S. Solomkin, MD, professor in the department of surgery and director of research of the division of trauma/critical care at the University of Cincinnati College of Medicine. With this FDA approval, Avelox is indicated for the treatment of adults with cIAI, including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species. The FDA approval was based on results from clinical studies in cIAI patients showing that sequential I.V. or oral monotherapy with Avelox once daily was as effective as the widely used I.V. therapy piperacillin-tazobactam four times daily followed by oral amoxicillin-clavulanate twice daily. Avelox was effective at eradicating key pathogens, including E. coli and the anaerobe B. fragilis, which are the most commonly encountered bacteria in cIAI. "This FDA approval signals yet another important milestone for Avelox, following the approval of Avelox for treatment of complicated skin and skin structure infections in June," said Robert J. Spiegel, MD, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "By adding two new indications this year, Avelox has successfully expanded its utility as a broad-spectrum antibiotic. This will help toward Avelox becoming a fluoroquinolone of choice for its approved indications." Patients taking Avelox for cIAI treatment benefit from the convenience of once-daily therapy and not requiring dosage adjustments when switching from I.V. to oral therapy. Dosage adjustments also are not required for Avelox patients suffering from renal impairment. In October 2004, Schering-Plough acquired exclusive U.S. rights to market, sell and distribute Avelox from Bayer Pharmaceuticals Corporation. As holder of the New Drug Application (NDA) and patents for Avelox, Bayer completed the research and FDA submission related to this new indication. The FDA approval to treat cIAI is the sixth indication for Avelox, which is already approved in the United States to treat acute bacterial sinusitis (ABS); acute bacterial exacerbation of chronic bronchitis (ABECB); community acquired pneumonia (CAP) -- including CAP caused by multi-drug resistant Streptococcus pneumoniae (MRSP) and penicillin-resistant S. pneumoniae (PRSP); uncomplicated skin and skin structure infections (uSSSI); and complicated skin and skin structure infections (cSSSI). Avelox Studies in cIAI About Complicated Intra-Abdominal Infections (cIAI) About Avelox *MDRSP, multi-drug resistant S. pneumoniae, includes isolates previously known as PRSP (penicillin-resistant S. pneumoniae), and are strains resistant to two or more of the following antibiotic classes: penicillin (MIC greater than or equal to 2 mcg/mL), second generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. Safety Information About Avelox Patients who have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as levofloxacin should avoid taking Avelox. Patients who have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat should avoid taking Avelox. These medications include quinidine, procainamide, amiodarone and sotalol. Avelox is not for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. Avelox is not for children under the age of 18 years. Convulsions have been reported in patients receiving quinolone antibiotics. Patients should be sure to let their physician know if they have a history of convulsions. Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. Patients should take Avelox either 4 hours before or 8 hours after taking these products. Avelox is a registered trademark of Bayer AG and is used under license by Schering-Plough. REFERENCE:
SOURCE: Schering-Plough Corporation
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