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Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
Date:12/9/2008

12.9 -

Key Secondary Efficacy Endpoint

A Clinical Global Impression-Severity (CGI-S) scale rating of agitation was completed at baseline for each patient, prior to AZ-004 administration, to ensure comparability across groups. The CGI-S scale ranges from 1 (normal) to 7 (among the most extremely agitated patients). Baseline mean scores were similar across the three dose groups with a range of 4.0 to 4.1

In addition to the PEC score, the Clinical Global Impression-Improvement (CGI-I) is another commonly used scale to measure the reduction of agitation in patients over time, normally following therapeutic treatment. The CGI-I standard scale ranges from 1 (very much improved) to 7 (very much worse). At the 2-hour post-dose time point, a CGI-I scale rating was completed for each patient. CGI-I was the key secondary endpoint of the study. Both the 10 mg and the 5 mg doses of AZ-004 showed highly statistically significant differences versus placebo in the CGI-I scores at the 2-hour post-dose time point.


                          CGI-I Scores (Mean Values)

    Study Arm              2-Hour Post-Dose       p-Value
    10 mg AZ-004 (n=105)         1.9             < 0.0001
    5 mg AZ-004 (n=104)          2.1             < 0.0001
    Placebo (n=105)              3.0                 -


Additional Efficacy Endpoints

AZ-004 exhibited a rapid onset of effect. At 10 minutes post-dose, the first assessment following dosing, the 10 mg dose showed a highly statistically significant improvement in the PEC score (p < 0.0001), compared to placebo. The 10 mg dose sustained this statistically significant improvement at all measurement time points throughout the 24-hour study period, compared to placebo. As pre-specified in the statistical analysis plan, the 5 mg dose was not statistically tested at any time point other than
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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1. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
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