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Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
Date:7/24/2008

eligible for the study include those who are admitted through an emergency department and those who are already in-patients in a hospital setting, as long as they have acute agitation at the time of patient randomization. This study is the first AZ-004 study enrolling bipolar disorder patients. Alexza projects that this second Phase 3 clinical trial will take approximately 12 months to complete patient enrollment.

The primary endpoint for the study is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, measured at 2 hours after the first dose. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24-hour period.

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), bipolar disorder affects about 5.7 million American adults while schizophrenia afflicts about 2.4 million people in the United States. Market research among physicians and health-care providers 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 department, and are also treated as in-patients in psychiatric hospitals or psychiatric units in standard hospitals. Market research among psychiatrists indicates that these physicians currently treat acute agitation with intramuscular (IM) injections, rapid-dissolve tablets or standard tablets. IM injections are invasive,
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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