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Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
Date:6/9/2008

bipolar disorder are able to make informed decisions regarding their treatment in an acute agitated state and would prefer a treatment option that is rapid-acting and noninvasive.

Alexza believes there is a significant unmet medical need for an alternative treatment option for acute agitation that will provide a faster onset of effect, that is non-invasive and safe for medical personnel to administer, and will facilitate trust between the patient and the treating clinician.

About AZ-004 (Staccato loxapine)

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as atypical antipsychotics. The Staccato system technology used in AZ-004 is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free loxapine aerosol for deep lung delivery that results in IV-like pharmacokinetics. Alexza has now completed four clinical trials with AZ-004, this 344 patient Phase 3 study, a 50 subject Phase 1 study, a 129 patient Phase 2 study, and a 32 patient multiple-dose tolerability and PK study in schizophrenic patients.

The Company believes that the unique delivery of loxapine via the Staccato system will provide rapid onset of drug effect, as measured by a reduction in the signs and symptoms of acute agitation. In March 2007, Alexza announced positive initial results from a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial in 129 patients in an in-patient clinical setting. The 10 mg dose of AZ-004 met the primary endpoint of the clinical trial, which was a statistically significant reduction in the measure of agitation from baseline to the 2-hour post-dose time point, as compared to placebo. The 10 mg dose of AZ-004 also exhibited a rapid onset of effect, with a statistically significant improvement in the PEC scores at 20 minutes post-dose, as compared to placebo, and sustained effectiveness through
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SOURCE Alexza Pharmaceuticals, Inc.
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