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Alexza Presents Staccato® Loxapine Responder Analyses in Agitated Adult Patients with Schizophrenia or Bipolar Disease at the 2011 USPMHC Annual Conference
Date:11/8/2011

MOUNTAIN VIEW, Calif., Nov. 8, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:  ALXA) today announced that it is presenting at the 24th Annual U.S. Psychiatric and Mental Health Congress, being held November 7 - 10, 2011.  The abstract and poster presentation, entitled "Treating Agitation with Inhaled Loxapine (AZ-004): Responder Analyses in Patients with Schizophrenia or Bipolar Disorder", is being presented today by Dr. James V. Cassella, Alexza's Senior Vice President of Research and Development.  Alexza has previously reported and presented the primary findings of its two Phase 3 clinical trials with Staccato loxapine.  In this presentation, Alexza is presenting additional analyses of these data, using two different responder methodologies.

Methodologies

The efficacy of Staccato loxapine in treating agitation was measured using the PANSS-Excited Component (PEC) and Clinical Global Impression - Improvement (CGI-I) scales in two Phase 3 randomized, double-blind, placebo-controlled trials in agitated patients with schizophrenia (n=344) or bipolar I disorder (n=314).  At the beginning of the treatment period, patients received a single inhalation of either 0mg (placebo), 5mg or 10mg of Staccato loxapine.  The primary endpoint was successfully achieved in both studies and has been previously reported and published.  As a further efficacy assessment, two responder analyses, PEC40 and CGI-Improvement, were conducted with responders defined as: (1) patients with a >40% decrease from baseline in the total PEC score (starting at 10 minutes post-dose); and (2) patients rated as "much improved" or "very much improved" on the CGI-I scale (assessed at 2 hours post-dose).  Responder analyses are important as they are a method to determine the magnitude of clinical relevance of patient response to a treatment.

PEC40 Responders Analysis

In agitated patients with schizophreni
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SOURCE Alexza Pharmaceuticals, Inc.
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