Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Pha...(the acute treatment of agitation inschiz...),Health

Date:12/9/2008

the acute treatment of agitation in schizophrenic or bipolar disorder patients, has completed both of the planned Phase 3 clinical trials. The Company has completed its end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine), which is intended for the acute treatment of migraine headache, and it has advanced AZ-104 (Staccato loxapine) to Phase 2 testing. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. In addition, AZ-002 (Staccato alprazolam) has completed a Phase 2a proof-of-concept clinical trial for the acute treatment of panic attacks -- an indication the Company is not planning to pursue -- and is being assessed for other possible indications and renewed clinical development. More information, including this and past press releases from Alexza, is available online at http://www.alexza.com.

Safe Harbor Statement

This press release includes forward-looking statements regarding the development, therapeutic potential, efficacy and safety of AZ-004. Any statement describing a product candidate or Alexza's goals, expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Re
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SOURCE Alexza Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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1. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
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