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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

5 mg dose was not statistically tested at the time points other than the 2-hour time point, as per the statistical analysis plan, but the mean changes in PEC scores demonstrated a dose response at all time points.

A dose response pattern for AZ-004 was also apparent, as measured by the need for a patient to require more than one dose of study drug by the 4-hour post-first dose time point. Compared to the 44% of the placebo group that required more than one dose of the study drug, only 25% of the 10 mg group (p = 0.0039) and 32% of the 5 mg group (p = 0.085) required more than one dose of study drug.

A responder analysis was conducted using the CGI-I scale. A responder was defined as having a CGI-I score at 2 hours after the first dose of either a 1 (very much improved) or 2 (much improved). Both the 5 mg (57% responders; p = 0.0015) and 10 mg (67% responders; p < 0.0001) doses of AZ-004 were statistically superior to placebo (36% responders).

Safety Evaluations

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 (> 10% in any treatment group) were taste (dysgeusia), dizziness, sedation and headache. These side effects were generally mild to moderate in severity, and occurred in both drug and placebo dose groups.

Treatment Emergent Side Effects

(> 2% in any treatment group)

Placebo 5 mg AZ-004 10 mg AZ-004

Term (n=115) (n=116) (n=113)

Dysgeusia 3 % 9 % 11 %

Dizziness 10 % 5 % 11 %

Sedation 10 % 13 % 11 %

Oral

Hypoaesthesia 0 % 1 % 4 %

Headache 14 % 3 % 3 %'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
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