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Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
Date:12/9/2008

or acute agitation: speed of onset, reliability of medication delivery and patient preference. The Company believes AZ-004 is a product candidate that has the potential to be the first product, if approved, that would be able to both meet these needs for most agitation sufferers and allow physicians to effectively respond to the potential rapid escalation of an acute agitation episode.

About AZ-004 (Staccato loxapine)

AZ-004 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known generally as antipsychotics. The Staccato system is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like pharmacokinetics. Alexza has now completed five clinical trials with AZ-004, enrolling more than 800 patients, and has announced positive results from all of these studies.

These five studies include a 50 subject Phase 1 study in healthy volunteers, a 129 patient Phase 2 study in agitated schizophrenic patients, a 32 patient multiple-dose tolerability and pharmacokinetic study in non-agitated schizophrenic patients, a 344 patient Phase 3 study in schizophrenic patients with acute agitation, and a 314 patient Phase 3 study in bipolar disorder patients with acute agitation. Alexza completed an end- of-Phase 2 meeting with the FDA for AZ-004 in September 2007, and believes it has a clear understanding of the development requirements for filing an NDA for AZ-004.

In the previously reported Phase 3 study in agitated schizophrenic patients, both the 5 mg and 10 mg doses of AZ-004 met the primary endpoint of the trial and the key secondary endpoint of the trial, both doses showing a highly statistically significant reduction in agitation in both endpoints, as compared to placebo. The 10 mg dose of AZ-004 exhibited a rapid onset of effect, w
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SOURCE Alexza Pharmaceuticals, Inc.
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Related medicine technology :

1. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
2. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
3. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
4. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
5. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
6. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
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