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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

-I responders, compared with 27.6% of placebo patients.  In both patient populations, the CGI-I responders were statistically significantly greater for patients treated with either dose of Staccato loxapine, compared to patients who received Staccato placebo.  The results for the CGI-I Responders analysis are summarized below.

Staccato Loxapine CGI-I Responder Analysis2-Hour CGI-Improvement(% of Patients Rated as "Much Improved" or "Very Much Improved")Schizophrenia

Bipolar DisorderStaccato Loxapine Dose Group

Patients

Patients10mg

67%

74%5mg

57%

66%Placebo

36%

28%About Alexza Pharmaceuticals, Inc.

Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza's technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.  The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. (Click here to see an animation of how the Staccato system works.)

ADASUVE™ (Staccato loxapine) is Alexza's lead program, which is being developed for the acute treatment of agitation in adults with schizophrenia or bipolar disorder.  Alexza completed and announced positive results from both of its Phase 3 clinical trials and initially submitted the ADASUVE NDA in December 2009.  In October 2010, the Company received a Complete Response Letter from the FDA regarding the application.  The Company completed an end-of-review meeting w
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SOURCE Alexza Pharmaceuticals, Inc.
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