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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

s. These side effects were generally mild to moderate in severity, and occurred in both drug and placebo dose groups.

About Patients with Acute Agitation

According to the National Institute of Mental Health, schizophrenia afflicts about 2.5 million adults and bipolar disorder affects about 5.7 million adults in the US. Agitation, characterized by unpleasant arousal, tension, irritability and hostility, is one of the most common and severe symptoms of schizophrenia and bipolar disorder. In about half the cases, it can require hospitalization. About 70% of those who experience agitation will have one to six episodes per year.

Treated patients are generally given intramuscular injections of an atypical antipsychotic drug or a sedative medication. However, intramuscular injections are invasive, can take 30 to 60 minutes to begin to work, frequently require restraints, are often disconcerting to patients and can be dangerous to the medical personnel administering the injection. Alexza believes that many schizophrenic and bipolar patients can make informed decisions regarding their treatment in an acute agitative state and would prefer a noninvasive treatment. Alexza also believes there is a significant unmet medical need for a fast-acting, noninvasive treatment of acute agitation in schizophrenic and bipolar patients.

Conference Call

At 5:00 p.m. Eastern Time today, September 18, Alexza will host an investor conference call to discuss AZ-004 (Staccato loxapine). A replay of the call will be available for two weeks following the call. The conference call, replay and webcast are open to all interested parties.

To access the conference call via the Internet, go to http://www.alexza.com, under the "Investor Relations" link. Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required. To access the live conference cal
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
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