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Alexza Announces Resubmission of AZ-004 (Staccato® Loxapine) NDA
Date:8/5/2011

MOUNTAIN VIEW, Calif., Aug. 5, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in October 2010.  The Company believes this is a Class 2 resubmission with a six-month review cycle.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

In addition to the data from the original NDA and additional analyses of some of those data, the AZ-004 resubmission contains new data from the successfully completed human factors study, stability data from new production batches manufactured late last year, updated manufacturing and controls sections addressing findings from the Company's Pre-Approval Inspection, and updated draft labeling and a comprehensive REMS proposal.

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.)

AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenia or bipolar di
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SOURCE Alexza Pharmaceuticals, Inc.
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