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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

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About Acute Agitation

Acute agitation, characterized by unpleasant arousal, tension, irritability and hostility, is one of the most common and severe symptoms of many major psychiatric disorders, including schizophrenia and bipolar disorder. According to the National Institute of Mental Health (NIMH), schizophrenia afflicts about 6.0 million adults in the United States and bipolar disorder affects about 5.7 million American adults. Company-sponsored market research indicates that over 90% of these patients will experience agitation during their lifetime and that about 70% of those who experience agitation will have one to six episodes per year. Agitated patients are often treated in an emergency room setting, and are also treated as in-patients in psychiatric hospitals or psychiatric units in standard hospitals.

Market research indicates that physicians currently treat acute agitation with intramuscular (IM) injections, rapid-dissolve tablets or standard tablets. IM injections are invasive, can be disconcerting to patients as they often require the use of restraints, and can be dangerous to the medical personnel while they attempt to inject the patient. IM injections can also take up to 60 minutes to work. Oral tablets provide convenience of dosing but have a slower onset of action. Market research among physicians has identified speed of onset as an important factor that affects their choice of therapy for treating acute agitation. Published literature suggests that many patients with schizophrenia or
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SOURCE Alexza Pharmaceuticals, Inc.
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