Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophreni... (/p (n112) 17.6 ...)

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Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients

Date:9/2/2008

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(n=112) 17.6 9.0 < 0.0001

5 mg AZ-004

(n=116) 17.8 9.8 0.0004

Placebo

(n=115) 17.4 11.8 -

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). Scores were similar across the three dose groups with a range of 3.9 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, which was the key secondary endpoint of the study. Both the 10 mg and the 5 mg doses of AZ-004 showed 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=112) 2.1 < 0.0001

5 mg AZ-004 (n=115) 2.3 0.0015

Placebo (n=115) 2.8 -

Additional Efficacy Endpoints

The 10 mg dose of AZ-004 also exhibited a rapid onset of effect. At 10 minutes post-dose, the 10 mg dose showed a 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. The
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