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Actavis plc announces positive topline results fro phase III program of ceftazidime-avibactam in patients with Complicated Intra-Abdominal Infections(cIAI)

Tuesday, 19 Aug 2014 07:30am EDT 

Actavis plc:Confirmed positive topline results from RECLAIM-1 and -2, pivotal Phase III studies evaluating the potential for the investigational antibiotic, ceftazidime-avibactam as a treatment for adult hospitalized patients with complicated intra-abdominal infections.Ceftazidime-avibactam consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor (avibactam).Compound is being developed to treat a broad range of Gram-negative bacterial infections, which are becoming resistant to antibiotics and pose an increasing threat to public health.Says global RECLAIM-1 and RECLAIM-2 Phase III studies both evaluated safety and efficacy of ceftazidime-avibactam, administered intravenously as two hour infusion (2000 mg / 500 mg).Saysp lus metronidazole, compared to meropenem, administered intravenously as a 30-minute infusion (1 g), in hospitalized adult patients with complicated intra-abdominal infections.Data from the RECLAIM-1 and RECLAIM-2 studies were analyzed as a single-pooled dataset with the agreement of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 

Company Quote

1.64 +0.62%
19 Dec 2014