Cubist Pharmaceuticals Inc announced that data from its two pivotal phase 3 trials studying the safety and efficacy of its flagship antibiotic product Cubicin (daptomycin for injection) have been published in the June 15 issue of Clinical Infectious Diseases (CID).
Cubicin, the first in a new class of antibiotics, was approved in September 2003 by the US Food & Drug Administration (FDA) for the indication of complicated skin and skin structure (cSSS) infections caused by certain Gram-positive organisms.
The manuscript presents detailed data from the two randomized, international, multi-center phase 3 trials that demonstrated the safety and efficacy of Cubicin in the treatment of cSSS infections.
In the study, of 1,092 patients enrolled in the two trials, 534 received Cubicin and 558 received the comparator agents, either a semi-synthetic penicillin or vancomycin. Patients, aged 18-85 years, were enrolled with Gram-positive cSSS infections that necessitated hospitalization, including wound infections, major abscesses, and infected ulcers; minor or superficial infections (e.g., simple abscesses and uncomplicated cellulitis) were excluded.
Both studies, individually and collectively, met the pre-defined statistical criteria of non-inferiority (comparability) across all efficacy populations, the results were robust and consistent across all pre-defined patient populations, across different species of infecting Gram-positive organisms, across different types of infection and for primary clinical outcomes (test of cure) and post-treatment relapse rates.
Cubicin demonstrated comparable efficacy to comparator against methicillin-susceptible Staphylococcus aureus (MSSA).
Robert J Perez, senior vice president of Sales & Marketing at Cubist commented on the publication, "For the first time ever, physicians have available to them a once-daily, rapidly bactericidal antibiotic that is as efficacious as the currently marketed standards of therapy in treating cSSS infections, regardless of the resistance profile of the Gram-positive pathogen present."
"With the incidence of MRSA rising at an alarming rate both in the hospital and in the community, physicians increasingly need reliable and safe broad-spectrum Gram-positive agents. We believe Cubicin directly addresses this growing unmet medical need. In addition," Mr. Perez continued, "due to its safety profile and convenient once-daily dosing, we believe Cubicin may confer economic benefits to the medical community as well."
Cubicin is indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms.