ZYVOX for ORAL SUSP Rx

Adults

Nosocomial Pneumonia

• A randomized, multicenter, double-blind trial evaluated the efficacy and safety of Zyvox IV Injection in adults with clinically and radiologically documented nosocomial pneumonia. Patients were randomly assigned 1:1 to receive either Zyvox IV Injection (n=203) 600mg every 12 hours or vancomycin (n=193) IV 1g every 12 hours for 7 to 21 days. Both groups received concomitant aztreonam (1 to 2g every 8 hours IV). 

• Of the study participants, 122 linezolid-treated patients and 103 vancomycin-treated patients were clinically evaluable. The cure rates were 57% for linezolid-treated patients and 60% for vancomycin-treated patients. The cure rates in patients with ventilator-associated pneumonia were 47% for linezolid-treated patients and 40% for vancomycin-treated patients. The cure rates in the MITT analysis were 57% in linezolid-treated patients and 46% in vancomycin-treated patients.

• The following cure rates were observed at the test-of-cure visit for microbiologically evaluable adults with nosocomial pneumonia for the Zyvox and vancomycin treatment arms, respectively:

• Staphylococcus aureus: 61% vs 61%.

• Methicillin-resistant S. aureus: 59% vs 70%.

• Streptococcus pneumoniae: 100% vs 90%.

Complicated Skin and Skin Structure Infections

• A randomized, multicenter, double-blind, double-dummy trial evaluated the efficacy and safety of Zyvox IV Injection in adults with clinically documented complicated skin and skin structure infections for a total of 10 to 21 days of treatment. Patients were randomly assigned to receive either Zyvox IV Injection (n=203) 600mg every 12 hours; or Zyvox Tablets (n=193) 600mg every 12 hours; or oxacillin IV 2g every 6 hours followed by dicloxacillin 500mg every 6 hours orally. Concomitant aztreonam was administered if clinically indicated.

• Of the study participants, 245 linezolid-treated patients and 242 oxacillin-treated patients were clinically evaluable. The cure rates were 90% for linezolid-treated patients and 85% for oxacillin-treated patients. The cure rates in the MITT analysis were 86% in linezolid-treated patients and 82% in oxacillin-treated patients.

• The following cure rates were observed at the test-of-cure visit for microbiologically evaluable adults with complicated skin and skin structure infections for the Zyvox and oxacillin/dicloxacillin treatment arms, respectively:

• Staphylococcus aureus: 88% vs 86%.

• Methicillin-resistant S. aureus: 67% vs (-)%.

• Streptococcus agalactiae: 100% vs 50%.

• Streptococcus pyogenes: 69% vs 75%.

Diabetic Foot Infections

• A randomized, multicenter, open-label trial evaluated the efficacy and safety of Zyvox IV Injection in adult diabetic patients with clinically documented complicated skin and skin structure infections (“diabetic foot infections”) for a total of 14 to 28 days of treatment. 

• Patients were randomly assigned to receive Zyvox IV or orally 600mg every 12 hours; or ampicillin/sulbactam 1.5 to 3g IV; or amoxicillin/clavulanate 500 to 875mg every 8 to 12 hours orally. If ampicillin/sulbactam was not marketed, amoxicillin/clavulanate 500mg to 2g every 6 hours was used. 

• Patients in the comparator group could also be treated with vancomycin 1g every 12 hours IV if MRSA was isolated from the foot infection. In either treatment groups, patients who had Gram-negative bacilli isolated from the infection site could also receive aztreonam 1 to 2g every 8-12 hours IV. There were 212 linezolid-treated patients and 105 comparator-treated patients who were clinically evaluable.

• In the ITT population, the cure rates were 68.5% in linezolid-treated patients and 64% in the comparator-treated patients. In the clinically evaluable patients, the cure rates were 83% in linezolid-treated patients and 73% in comparator-treated patients.

• The following cure rates were observed at the test-of-cure visit for microbiologically evaluable adults with diabetic foot infections for the Zyvox and comparator treatment arms, respectively:

• Staphylococcus aureus: 78% vs 69%.

• Methicillin-resistant S. aureus: 71% vs 67%.

• Streptococcus agalactiae: 86% vs 56%.

Vancomycin-Resistant Enterococcal Infections

• A randomized, multicenter, double-blind trial evaluated the efficacy and safety of a Zyvox in adults with documented or suspected vancomycin-resistant enterococcal infection. The trial compared a high dose of Zyvox (600mg) (n=79) to a low dose of Zyvox (200mg) (n=66) given every 12 hours either IV or orally for 7 to 28 days. All patients could receive concomitant aztreonam or aminoglycosides.

• The ITT population with documented vancomycin-resistant enterococcal infection at baseline consisted of 65 patients in the high-dose arm and 52 in the low-dose arm.

• The following cure rates were observed at the test-of-cure visit for ITT adults with documented vancomycin-resistant enterococcal infections for the Zyvox 600mg and Zyvox 200mg treatment arms, respectively:

• Any site: 67% vs 52%.

• Any site with associated bacteremia: 59% vs 29%.

• Bacteremia of unknown origin: 50% vs 29%.

• Skin and skin structure: 69% vs 100%.

• Urinary tract: 63% vs 60%.

• Pneumonia: 67% vs 0%.

• Other (includes sources of infection such as hepatic abscess, biliary sepsis, necrotic gall bladder, pericolonic abscess, pancreatitis, and catheter-related infection): 85% vs 39%.

Pediatric Patients

Infections due to Gram-positive Bacteria

• A randomized, open-label, comparator-controlled clinical study evaluated the efficacy and safety of Zyvox in pediatric patients ranging in age from birth to 11 years with infections caused by the documented or suspected Gram-positive bacteria.

• One group of patients received Zyvox IV Injection 10mg/kg every 8 hours followed by Zyvox for Oral Suspension 10mg/kg every 8 hours. Another group received vancomycin 10 to 15 mg/kg IV every 6 to 24 hours, based on age and renal clearance. The third arm of the study included patients with a confirmed vancomycin-resistant Enterococcus faecium (VRE) infections and received Zyvox 10m/kg every 8 hours IV and/or orally. Treatment duration for all patients was for a total of 10 to 28 days.

• In the ITT population, there were 206 linezolid-treated patients and 102 vancomycin-treated patients.

• The following cure rates were observed at the test-of-cure visit for pediatric patients in the ITT population for the Zyvox and vancomycin treatment arms, respectively:

• Any diagnosis: 81% vs 83%.

• Complicated skin and skin structure infections: 85% vs 91%.

• Nosocomial pneumonia: 72% vs 92%.

• The following cure rates were observed at the test-of-cure visit for pediatric patients in the MITT population (defined as ITT patients with an isolated Gram-positive pathogen at baseline) for the Zyvox and vancomycin treatment arms, respectively:

• Any diagnosis: 80% vs 90%.

• Complicated skin and skin structure infections: 86% vs 96%.

• Nosocomial pneumonia: 83% vs 100%.

• The following cure rates were observed at the test-of-cure visit for pediatric patients in the clinically evaluable population for the Zyvox and vancomycin treatment arms, respectively:

• Any diagnosis: 91% vs 91%.

• Complicated skin and skin structure infections: 94% vs 96%.

• Nosocomial pneumonia: 100% vs 100%.