Seroquel XR™ Receives Approval From FDA For Maintenance Treatment Of Schizophrenia

Main Category: Schizophrenia
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 Nov 2007 - 10:00 PDT

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AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets for maintenance treatment of schizophrenia in adult patients. On May 17, 2007, the FDA approved SEROQUEL XR for the acute treatment of schizophrenia in adult patients.

Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for long-term treatment options for schizophrenia to help reduce the risk of the recurrence of acute psychotic episodes.1,2

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% 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 percent in the SEROQUEL XR group versus 68.2 percent 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 2007.3

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 1% of the population aged 18 and older.4,5

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) were randomized and 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 randomization to psychiatric relapse (hospitalization for worsening schizophrenia, increase in PANSS Total score ≥30%, Clinical Global Impression-Global Improvement [CGI-I] score ≥6, or need for additional antipsychotic medication to treat psychosis). 3

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% of patients) treatment emergent adverse events for the SEROQUEL XR group versus placebo group in the randomized phase were insomnia (8.5% vs 17.5%) and headache (7.4% vs 4.9%).3,6

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 program and planned regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalized 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.

*Estimate based upon: (1) assumptions as to persistence (the number of prescriptions per patient) based upon 2002 market research; and (2) projections of prescriptions since launch based upon information available in the US and 13 of the 50 other countries in which SEROQUEL is marketed.

References

1 Altamura AC, Bobo WV, Meltzer HY. Factors affecting outcome in schizophrenia and their relevance for psychopharmacological treatment. Int Clin Psychopharmacol. 2007;22:249-267.

2 Robinson D et al. "Predictors of Relapse Following Response From a First Episode of Schizophrenia or Schizoaffective Disorder." Arch Gen Psychiatry. 1999; 56: 241-247.

3 Peuskens J, Trivedi J, Malyarov S, et al. Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: A randomized, placebo-controlled trial in clinically stable patients. Psychiatry 2007;4(11):34-50.

4 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR). Fourth Edition. Arlington, VA, 2000. 299.

5 National Alliance for the Mentally Ill: About Mental Illness/Schizophrenia fact sheet. Reviewed by Kenneth Duckworth, MD: February 2007. Accessed on September 24, 2007 here.

6 SEROQUEL XR US Prescribing Information.

http://www.astrazeneca.com