Cubist Pharmaceuticals, Inc. announced that it has begun shipping its flagship antibiotic product, Cubicin, to US hospitals. Cubist received US Food & Drug Administration (FDA) marketing approval for Cubicin on September 12, 2003.
Cubicin is indicated for the treatment of complicated skin and skin-structure infections (cSSSI) caused by gram-positive bacteria, including those caused by MRSA (methicillin-resistant staphylococcus aureus) and MSSA (methicillin-susceptible S. aureus).
Cubicin is currently the only once-daily rapidly bactericidal antibiotic proven effective against both MRSA and MSSA. Michael Bonney, president and CEO of Cubist commented on the launch: "Today marks another important milestone at Cubist, as we have begun filling the first commercial orders for Cubicin. Since our September approval, we have finished hiring and training our Cubicin national sales team and we believe our team is well prepared to effectively and efficiently introduce Cubicin to the infectious disease community at key institutions across the country. To date, we have been pleased with the level of interest in the product and the number of hospital formularies onto which Cubicin has been placed. "
Cubicin is an antibacterial agent from a new class of antibiotics called cyclic lipopeptides, and has clinical utility in the treatment of infections caused by aerobic gram-positive bacteria. The in vitro spectrum of activity of Cubicin encompasses most clinically relevant gram-positive pathogenic bacteria, including bacterial isolates resistant to methicillin, vancomycin and linezolid.
In the US, MRSA now accounts for nearly 60 per cent of staphylococcal infections in hospitals, and the incidence of MRSA in the community is on the rise as well. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cubicin and other antibacterial drugs, Cubicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Patients receiving Cubicin should be observed for the development of muscle pain or weakness and have creatine phosphokinase (CPK) levels monitored weekly. Cubicin is not indicated for the treatment of pneumonia.
The most commonly reported adverse events in the cSSSI clinical trials in adults were constipation, nausea and headache. Cubicin is indicated 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), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only).