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news.AstraZeneca has said that the FDA has approved its once-daily Seroquel extended-release tablets for maintenance treatment of schizophrenia in adult patients.
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The FDA approval for maintenance treatment of schizophrenia was based on clinical trial results in which patients who had responded to Seroquel for the treatment of schizophrenia for 16 weeks were randomized and either continued on Seroquel or were switched to placebo. The primary endpoint was the time from randomization to psychiatric relapse.
In the clinical trial supporting this approval, patients with schizophrenia who were treated with Seroquel experienced a significantly longer time to relapse, compared with patients receiving placebo. Patients receiving Seroquel demonstrated an 84% reduction in the relative risk of relapse. Results showed the estimated risk of relapse after six months was 14.3% in the Seroquel group versus 68.2% in the placebo group.
Mark Scott, executive director for development, AstraZeneca, said: “The clinical trial results provided compelling evidence for reducing the risk of relapse when these patients are treated with Seroquel.”