Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for options for long-term treatment of schizophrenia to help reduce the risk of the recurrence of acute psychotic episodes.
In the clinical trial supporting this approval, patients with schizophrenia who were treated with SEROQUEL XR experienced a significantly longer time to relapse, compared with patients receiving placebo. Patients receiving SEROQUEL XR demonstrated an 84 per cent reduction in the relative risk of relapse (hazard ratio 0.16; p<0.0001). Results showed the estimated risk of relapse after six months was 14.3 per cent in the SEROQUEL XR group versus 68.2 per cent in the placebo group (p<0.0001). Differences in relapse rate between active treatment and placebo were large enough to require the study to be stopped early. The complete results of the clinical trial appear in the November 2007 issue of the journal Psychiatry 2007.
Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, illogical thinking, and flat or blunted emotions, affecting over 2 million American adults – about one per cent of the population aged 18 and older.
The FDA approval for maintenance treatment of schizophrenia was based on clinical trial results in which patients who had responded to SEROQUEL XR for the treatment of schizophrenia for 16 weeks (n=197) either continued on SEROQUEL XR (n=94; 400-800 mg/day, flexibly dosed) or were switched to placebo (n=103). The primary endpoint was the time from randomisation to psychiatric relapse (hospitalisation for worsening schizophrenia, increase in PANSS Total score ≥30 per cent, Clinical Global Impression-Global Improvement [CGI-I] score ≥6, or need for additional antipsychotic medication to treat psychosis).
The adverse reactions reported for SEROQUEL XR were generally consistent with those reported in the short-term placebo-controlled schizophrenia trials. The most common (>5 per cent of patients) treatment emergent adverse events for the SEROQUEL XR group versus placebo group in the randomised phase were insomnia (8.5 per cent vs. 17.5 per cent) and headache (7.4 per cent vs. 4.9 per cent).
About SEROQUEL
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 25 million patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the USA for the treatment of bipolar depression. SEROQUEL XR was launched for the treatment of schizophrenia in the US in 2007, and its clinical development programme and planned regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalised anxiety disorder (GAD).
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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