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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

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Somnolence 3 % 3 % 3 %

Nausea 5 % 1 % 2 %

Vomiting 3 % 1 % 1 %

Agitation 3 % 1 % 0 %

There were two serious adverse events reported during the trial: exacerbation of schizophrenia (1 patient in the placebo group) and gastroenteritis (1 patient in the 10 mg group). Both of these events were scored by the investigator as "unrelated" to study drug.

The Agitation-Calmness Evaluation Scale (ACES) was recorded at baseline and at 2 hours after dosing, to determine the level of patient sedation. Baseline ACES scores were similar across the three patient groups. Mean scores at 2-hours post-dose for the 5 mg and 10 mg AZ-004 groups were in the range of "normal" to "mild calmness".

"These positive Phase 3 results, corroborating our Phase 2 findings, show that AZ-004 is a viable product candidate to treat acute agitation," said Thomas B. King, Alexza President and CEO. "We are very encouraged with the pace at which we have developed into a Phase 3 company. In addition to our clinical successes, we are aggressively escalating many commercialization activities, including our manufacturing scale-up, quality systems, regulatory affairs and commercial operations, 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, September 2, 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 live conference call via phone, dial 800-299-8538. International callers may access the live call by dialing 617-786-2902. The reference number to enter the call is 39290605.

The replay of the conference call may be accessed via the I
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SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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