Actavis Reports Positive Results From Ceftazidime-Avibacta Phase III Studies

(RTTNews) - Actavis plc (ACT) 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.

The global RECLAIM-1 and RECLAIM-2 Phase III studies both evaluated the safety and efficacy of ceftazidime-avibactam, administered intravenously as a two hour infusion (2000 mg / 500 mg) plus metronidazole, compared to meropenem, administered intravenously as a 30-minute infusion (1 g), in hospitalized adult patients with complicated intra-abdominal infections. In the RECLAIM-1 and RECLAIM-2 Phase III studies, ceftazidime-avibactam met the objective of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomization. Also, ceftazidime-avibactam was effective in treating cIAI patients infected with ceftazidime-resistant bacteria. The most commonly reported adverse events for ceftazidime-avibactam in combination with metronidazole were diarrhea, nausea, vomiting and fever.

Ceftazidime-avibactam is being jointly developed with Astra Zeneca. Forest Laboratories LLC., a subsidiary of Actavis plc, holds the rights to commercialize ceftazidime-avibactam in North America, while AstraZeneca holds the rights to commercialize ceftazdime-avibactam in the rest of the world.