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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

3% 4% 3% Anxiety 0% 0% 2% Headache 9% 4% 2% Dry mouth 2% 2% 1% Nausea 2% 0% 1% Stomach discomfort 2% 3% 1% Diarrhea 3% 1% 0% Skin rash 2% 1% 0%

"The positive results from this second Phase 3 study, corroborating our first Phase 3 findings, show that AZ-004 has the potential to be a viable product to acutely treat agitation," said Thomas B. King, Alexza President and CEO. "We are very encouraged with the pace at which we have developed into a pre-NDA stage company. In addition to our clinical successes, we are aggressively escalating many commercialization activities, including our commercial manufacturing scale-up, quality systems, regulatory affairs and strategic marketing initiatives, as we continue to track toward our planned AZ-004 NDA submission in early 2010."

Conference Call Information

Alexza will host a conference call later today, Tuesday, December 9, 2008 at 5:00 p.m. Eastern Time. A replay of the call will be available for two weeks following the event. The conference call and replay are open to all interested parties.

To access the conference call via the Internet, go to http://www.alexza.com, under the "Investor Relations" link. Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required. Interested parties may also pre-register to avoid pre-call delays at https://www.theconferencingservice.
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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
7. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
8. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
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