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Alexza Announces Submission of AZ-004 (Staccato(R) Loxapine) NDA
Date:12/14/2009

tic value of drugs," said Alejandro C. Zaffaroni, PhD, Chairman Emeritus and Co-Founder of Alexza. "It is splendid that Alexza has reached its first NDA so quickly and is on the doorstep of its first Staccato-based product, Staccato loxapine."

AZ-004 Clinical Results Summary

The AZ-004 NDA contains efficacy and safety data from more than 1600 patients and subjects who have been studied in thirteen different clinical trials. In 2008, the Company successfully initiated and completed two pivotal Phase 3 clinical trials. In these studies, both doses of AZ-004 (5 and 10 mg) met the primary and key secondary endpoints of the studies, with highly statistically significant reductions in agitation, as compared to placebo. Additionally, the 10 mg dose of AZ-004 exhibited a rapid onset of effect, with statistically significant reductions in agitation at 10 minutes post-dose, the first time point measured. The reduction of agitation was sustained through the 24-hour study period. In both studies, the administration of AZ-004 was generally safe and well tolerated.

In 2009, Alexza initiated and completed five non-pivotal safety and NDA-supporting studies for AZ-004. Alexza believes these data, along with data from the other efficacy and safety trials conducted with AZ-004, adequately demonstrate the efficacy and safety of AZ-004 for the proposed indication.

Agitation Market Opportunity

Episodes of agitation afflict many people suffering from major psychiatric disorders, including schizophrenia, which affects approximately 2.4 million adults in the United States, and bipolar disorder, which affects approximately 5.7 million adults in the United States. More than 90% of these patients will experience agitation in their lifetime.

Agitation generally escalates over time with patients initially feeling uncomfortable, tense and restless. As the agitation intensifies, their behavior
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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Related medicine technology :

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3. Alexza Pharmaceuticals to Present at the Fourth Annual JMP Securities Healthcare Focus Conference
4. Alexza Announces Preliminary Results from its AZ-104 (Staccato(R) Loxapine) Phase 2b Trial in Patients with Migraine Headache
5. Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
6. Endo Pharmaceuticals and Alexza Pharmaceuticals Conclude Research Collaboration
7. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
8. Alexzas AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
9. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
10. Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
11. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
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