Forest Laboratories Announces Positive Top-line Data from Two Pivotal Phase III Trials of Ceftaroline for the Treatment of Community-acquired Bacterial Pneumonia (CABP) Requiring Hospi...(II Study Results The two Phase III c...),Health

The two Phase III clinical trials randomized 1,241 patients (1:1 randomization) and were designed to evaluate the efficacy, safety and tolerability of a 5-7 day treatment course of ceftaroline (600 milligram twice a day) compared with ceftriaxone (1 gram once a day), utilizing a non-inferiority design with a margin of 10%. The patients were hospitalized adults with moderate to severe CABP requiring treatment with intravenous antimicrobials. In the co-primary populations (modified intent-to-treat [MITT] and CE populations), 100% of subjects were PORT Risk Class 3 and 4.

In FOCUS I, ceftaroline-treated patients had a clinical cure rate of 86.6% compared with the ceftriaxone clinical cure rate of 77.7% in the CE population (95% confidence interval [CI] of treatment difference: +1.4, 15.4). In FOCUS II, the respective rates were 82.1% versus 77.2% (95% CI: -2.5, 12.5). For the MITT, the respective rates in FOCUS I were 83.8% versus 77.7% (95% CI: -0.2, 12.6) and in FOCUS II were 81.3% versus 75.5% (95% CI: -1.0, 12.7). According to the integrated data, in subjects infected with Streptococcus pneumoniae, the most common pathogen in CABP, the clinical cure rates achieved with ceftaroline were 85.5% and 68.6% for ceftriaxone.

For both studies combined, the percentage of patients who experienced an adverse event was similar between treatment groups. The adverse event rates for ceftaroline were consistent with previously reported trials. Discontinuation rates due to adverse events were also similar between treatment groups (3.1% ceftaroline versus 2.4% ceftriaxone).

About Ceftaroline and Ceftaroline/NXL104

Ceftaroline is a novel, bactericidal, injectable, broad-spectrum cephalosporin being developed as a therapeutic agent for the treatment of cSSSI and CABP which include gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and multi
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