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| |  Efficacy of Once-Daily Moxifloxacin in Treating Complicated Intra-Abdominal Infections Highlighted in Two Clinical Data Presentations at ICAAC SAN FRANCISCO, CA -- October 13, 2006 -- The efficacy of monotherapy with the once-daily, broad-spectrum antibiotic Avelox® (moxifloxacin HCl) in the treatment of complicated intra-abdominal infections (cIAI) was highlighted in two clinical data presentations by researchers here at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2006, Schering-Plough Corporation reported. Approximately 3.5 million Americans are diagnosed annually with cIAIs, which are caused by disease, trauma or surgery in the abdomen that can allow bacteria to leak from the gastrointestinal tract into adjacent tissue.1 "Complicated intra-abdominal infections often involve several different kinds of bacteria and require broad-spectrum antibiotic therapy for effective treatment," said Robert J. Spiegel, MD, chief medical officer and senior vice president, Schering-Plough Research Institute. "The data presented at ICAAC further underscore the efficacy of once-daily Avelox monotherapy in treating these infections." Avelox is the only marketed fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) as monotherapy to treat cIAI, and has been shown to be effective at eradicating the most common bacteria that cause cIAI, including E. coli and B. fragilis. Avelox is indicated to treat polymicrobial cIAI infections, including infections caused by mixed aerobic and anaerobic bacteria (bacteria that thrive without oxygen) commonly seen in patients with cIAI.2,3 About the ICAAC Data Presentations This prospective, randomized, open-label, multicenter study compared the efficacy and safety of moxifloxacin to that of combination therapy in the treatment of cIAI. Of 595 patients enrolled at 58 international centers, 584 (289 moxifloxacin, 295 control group) were valid for the intent-to-treat analysis. Patients received either intravenous (I.V.) followed by oral moxifloxacin (400 mg, once daily) or a sequential therapy with I.V. ceftriaxone (2 g daily) and metronidazole (0.5 g, three times daily) followed by oral dosing of amoxicillin/clavulanate (625 mg, three times daily) for 14 days. A switch to oral moxifloxacin (400 mg, once daily) or amoxicillin/clavulanate (625 mg, three times daily) was allowed per protocol after the third day of treatment for the two groups, respectively. In the study, moxifloxacin monotherapy was as effective as the combination regimen in treating patients with cIAI. Overall clinical cure rates were 80.9% in the group receiving moxifloxacin and 82.3% in the group receiving the combination therapy regimen. Duration of therapy, length of post-operative hospital stay and mortality rates were comparable for the two treatment groups. Both regimens were well tolerated. In the study, 19% of the moxifloxacin patients and 12.5% of the patients in the comparator arm experienced at least one drug-related adverse event. Moxifloxacin Efficacy Against Anaerobic Bacteria: Pooled Analysis from Two Complicated Intra-Abdominal Infection Trials (P. Pertel, M. Malangoni, L. Koeth, J. E. Ambler, S. Choudhri) This analysis, designed to assess the efficacy of moxifloxacin against anaerobic bacteria in cIAI, evaluated pooled data from two large cIAI clinical trials in which the effectiveness of I.V. to oral moxifloxacin (400 mg, once daily) was compared to treatment with combination therapies. In one trial, the comparator treatment was I.V. piperacillin-tazobactam (3.0/0.375 g, every 6 hours) followed by oral amoxicillin-clavulanic acid (800/114 mg, twice daily). In the second trial, the comparator treatment was the combination of I.V. ceftriaxone (2 g, once daily) and metronidazole (500 mg, three times daily) followed by oral amoxicillin-clavulanic acid (500/125 mg, three times daily). In these studies, clinical efficacy and bacteriological eradication rates were assessed at the test-of-cure visit. The pooled analysis showed that monotherapy with moxifloxacin 400 mg once daily provided clinical and bacteriological success rates against anaerobic pathogens comparable to combination therapy with either piperacillin/tazobactam or ceftriaxone/metronidazole in patients with cIAI. Overall, the combined cure rates were 80.4% (345/429) for patients treated with moxifloxacin and 80.4% (371/461) for patients in the combination therapy treatment arms. About Complicated Intra-Abdominal Infections (cIAI) About Avelox Avelox is approved for use in adult patients (18 years of age and older) for the treatment of: Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis; Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis; Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae; Uncomplicated Skin and Skin Structure Infections (uSSSI) caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes; Complicated Skin and Skin Structure Infections (cSSSI) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae; and Complicated Intra-Abdominal Infections (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. *MDRSP, Multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (Penicillin-resistant Streptococcus 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" 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. 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. Please see full prescribing information for Avelox available at www.AveloxUSA.com. 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SOURCE: Schering-Plough
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