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SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
Date:11/16/2007

tenance 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 Greater Than or Equal To 30%, Clinical Global Impression-Global Improvement [CGI-I]** score Greater Than or Equal To 6, or need for additional antipsychotic medication to treat psychosis).(3)

* Schizophrenic symptomatology is measured on 30-item Positive and

Negative Syndrome Scale (PANSS) scale. Each symptom was rated on a

severity scale from 1-7. PANSS positive (7 items), negative (7 items),

and general psychopathology (16 items) subscale scores were summarized

to give the PANSS total score.(8)

** The Clinical Global Impression (CGI) consists of 3 global scales or

items (Severity of Illness; Global Improvement; Efficacy Index). For

the primary endpoint of Study 004, item 2, the Global Improvement

scale, was used to evaluate patients. The Global Improvement scale

involves the physician rating total improvement whether or not, in the

physician's judgment, it is due entirely to drug treatment (1=very much

improved to 7=very much worse).(9)

The adverse reactions reported for SEROQUEL XR in the longer-term placebo- controlled schizophrenia trial were generally consistent with those reported in the short-term placebo-controlled schizophrenia trials. The most common (Greater Than or Equal To 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)

Launched in 1997, SEROQUEL has bee
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SOURCE AstraZeneca
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