Phase III results for ceftolozane/tazobactam for IntraAbdominal Infections;Cubist
Top-line results from a pivotal Phase III clinical trial of CXA 201 (ceftolozane/tazobactam), from Cubist Pharma, in complicated Intra-Abdominal Infections (cIAI) shows that in combination with metronidazole, the treatment met the FDA and EMA defined primary endpoints of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 26 - 30 days after the initiation of therapy and the non-inferiority margin was 10% (FDA) and 12.5% (EMA).
The treatment emergent adverse event rate for ceftolozane/tazobactam, in combination with metronidazole, was 44.0% and for meropenem was 42.7%. In this trial, the most commonly reported adverse events for ceftolozane/tazobactam in combination with metronidazole were nausea (7.9%), diarrhea (6.2%) and fever (5.2%). The cIAI trial results follow the positive data reported last month from a Phase III trial of ceftolozane/tazobactam compared to levofloxacin in patients with complicated Urinary Tract Infections. Cubist expects to submit applications for both indications to the FDA and EMA in 2014.
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