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Alexza to Initiate the First Phase 3 Trial for AZ-004 (Staccato(R) Loxapine) in Late Q1 2008
Date:9/18/2007

Z-004 in 129 schizophrenic patients with acute agitation. In that trial, the 10 mg dose of AZ-004 met the primary endpoint of the clinical trial, showing a statistically significant (p < 0.05) reduction in agitation compared to placebo. The primary endpoint in the trial was the change in the PANSS (Positive and Negative Symptom Scale) Excited Component (PEC) score at the 2-hour post-dose time point.

PEC Scores (Mean Values)

p-value

Study Arm Baseline 2-hour Post-Dose vs. placebo

10 mg AZ-004 17.3 8.8 0.0001

5 mg AZ-004 17.6 10.8 0.088

Placebo 17.7 12.7 -

The 10 mg dose of AZ-004 also exhibited a rapid onset of effect. At 20 minutes post-dose, the 10 mg dose showed statistically significant improvement in the PEC score, compared to placebo. The effectiveness of the 10 mg dose was sustained throughout the 24-hour study period, compared to placebo.

Using the Behavioral Activity Rating Scale (BARS), the 10 mg dose of AZ-004 showed statistically significant improvement, compared to placebo, beginning at 30 minutes. This response was sustained throughout the 24-hour study period, compared to placebo.

Clinical Global Impression-Severity (CGI-S) scale ratings to measure agitation were completed at baseline, immediately prior to AZ-004 administration. At the 2-hour post-dose time point, a Clinical Global Impression-Improvement (CGI-I) evaluation was completed for each patient. Both the 10 mg and the 5 mg doses of AZ-004 showed statistically significant improvements in the CGI-I scale, compared to placebo.

Side effects were recorded throughout the clinical trial period. The administration of AZ-004 was generally safe and well tolerated. The most common side effects reported were taste, sedation and dizzines
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SOURCE Alexza Pharmaceuticals, Inc.
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