CUBICIN® (daptomycin for injection)
 May 1 Press Briefing: The MRSA Threat
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CUBICIN® (daptomycin for injection), developed and launched by Cubist, is the only once-daily IV bactericidal antibiotic approved in the U.S. (at 4 mg/kg) for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains, also known as MRSA), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only).
CUBICIN is also approved in the U.S., at 6 mg/kg, for the treatment of S. aureus bloodstream infections (bacteremia), including right-sided infective endocarditis caused by MRSA and MSSA.
CUBICIN is the only IV antibiotic approved for this indication based on the results of a prospective, randomized, controlled registration trial.
Optimizing CUBICIN
CUBICIN continues to be studied. Cubist sponsored research underway includes the following Phase 2 and Phase 4 studies:
Studies of CUBICIN at higher doses than those in current approved indications:
- Prosthetic joint infections (comparative dosing)
- 6 and 8 mg/kg (6 week +/- 1 week treatment period)
- A slow to enroll trial/data expected in 2010
- MRSA Bacteremia – higher dose safety trial
- 10 mg/kg vs. vancomycin alone
- Initiated in Q308; patient enrollment underway
Patient populations (post-approval regulatory commitments)
- Pediatric (cSSSI)
- Safety & efficacy in 7 to 17 year olds: majority of sites initiated and some patients randomized: data expected in 1H10
- PK study in 2 to 6 year olds: enrollment completed - data expected in 1H10
- Renal-impaired
- PK study in high-dose (HD)/continuous ambulatory peritoneal dialysis (CAPD) has completed enrollment; results will be posted on clinicalstudyresults.org
- cSSSI safety/efficacy study protocol submitted to FDA Dec 2008
- IE combination therapy
- Safety and efficacy study; CUBICIN with and without gentamicin
- Sites open; patients are being screened
CUBICIN Mechanism of Action Video
CUBICIN—the first of a new antibiotic class, the cyclic lipopeptides—kills gram-positive bacteria without cell lysis. Watch a video that illustrates the mechanism of action of CUBICIN.
Video Reference: Silverman JA, Perlmutter NG, Shapiro HM. Correlation of daptomycin bactericidal activity and membrane depolarization in
Staphylococcus aureus.
Antimicrob Agents Chemother. 2003;47:2538-2544.
Click here for CUBICIN IP Information
CUBICIN Timeline
For full prescribing information (US medical professionals only),
www.cubicin.com. In the U.S., the CUBICIN Drug Information Hotline is
866-793-2786
Our current marketing partnerships for CUBICIN in countries outside the U.S. are summarized below:
| Marketing Partner |
Countries covered |
| AstraZeneca |
China and certain other countries in Asia, the Middle East and Africa |
| Kuhnil Pharmaceuticals |
South Korea |
| Medison Pharma, Ltd. |
Israel |
| Merck and Co., Inc. (Banyu Pharmaceutical Co.) |
Japan |
| Novartis Pharmaceuticals AG |
EU countries, Iceland, Liechtenstein, Norway, Switzerland, Australia, New Zealand, India and certain Central American, South American and Middle Eastern Countries. |
| Sepracor Pharmaceuticals |
Canada |
| TTY Biopharm Co., Ltd. |
Taiwan |
For more information on our International Partners,
click here.
CUBICIN® (daptomycin for injection) is indicated for the following infections: Complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).
S. aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative or anaerobic organisms.
The efficacy of CUBICIN in patients with left-sided infective endocarditis due to S. aureus has not been demonstrated. The clinical trial of CUBICIN in patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor. CUBICIN has not been studied in patients with prosthetic valve endocarditis or meningitis.
Patients with persisting or relapsing S. aureus infection or poor clinical response should have repeat blood cultures. If a culture is positive for S. aureus, MIC susceptibility testing of the isolate should be performed using a standardized procedure, as well as diagnostic evaluation to rule out sequestered foci of infection. Appropriate surgical intervention (e.g., debridement, removal of prosthetic devices, valve replacement surgery) and/or consideration of a change in antibiotic regimen may be required.
CUBICIN is not indicated for the treatment of pneumonia.
Patients receiving CUBICIN should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. CPK levels should be monitored weekly, and any unexplained elevations should be monitored more frequently.
CUBICIN should be discontinued in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevation >1000 U/L, or in patients without reported symptoms who have marked elevations in CPK (≥10X ULN).
Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache.
Please click on full prescribing information link above for additional information.
