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Cubist daptomycin

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Data from two ongoing, multicenter, open-label, dose-ranging studies of the bactericidal antibiotic for gram-positive infections showed a combined clinical success rate of 91% for a 4 mg/kg once-daily dose, the company reported at the CDC 4th Decennial Conference on Nosocomial and Healthcare-Associated Infections. In the first study, 31 patients diagnosed with bacteremia were treated with one of three daptomycin doses: 4 mg/kg once a day, 6 mg/kg once a day or 3 mg/kg twice daily. An additional seven patients were given "standard doses of an optimal comparator regimen, either vancomycin, oxacillin or nafcillin," according to the company. The second study assessed the same doses of daptomycin in 32 patients with Gram positive infections (including bacteremia) who were resistant to, refractory to, or contraindicated for vancomycin. A modified intent-to-treat analysis of the studies showed that treatment with daptomycin resulted in an 80% clinical success rate for bacteremic patients at the 4 mg/kg dose (8 of 10 patients) and 65% at the 6 mg/kg dose (11/17) compared with 71% in the comparator group (5/7). Clinical success in the non-bacteremia patients was 100% at the 4 mg once-daily dose (11/11) and 57% at the 6 mg/kg once-daily dose (4/7)
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