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Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
Date:9/2/2008

y, Alexza is developing AZ-004 to potentially offer an acute agitation treatment option that provides a fast onset of effect, that is noninvasive and safer to administer than injections, and that allows patients to be active participants in choosing acceptable treatment options.

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 completed four clinical trials with AZ-004 and has announced positive results from all four studies, including 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 PK study in non-agitated schizophrenic patients, and a 344 patient Phase 3 study in agitated schizophrenic patients. In July 2008, Alexza initiated a second Phase 3 clinical trial in bipolar disorder patients with acute agitation.

About Symphony Allegro

In December 2006, Alexza entered into a collaboration with Symphony Capital LLC, a biotech-focused private equity firm. Under the terms of the agreement, Alexza and Symphony Capital established Symphony Allegro, Inc., which is providing funding to Alexza to accelerate clinical and other related development activities of Staccato loxapine (AZ-004 and AZ-104) and Staccato alprazolam (AZ-002). Alexza has granted a license to certain intellectual property rights for the selected product candidates. Through a purchase option, Alexza retains the exclusive right, but not the obligation, to acquire 100% of the equity of Symphony Allegro at specified prices during the term of the agreement. If Alexza chooses not to exercise the purchase option, Symphony Allegro re
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SOURCE Alexza Pharmaceuticals, Inc.
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Related medicine technology :

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