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Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
Date:6/9/2008

MOUNTAIN VIEW, Calif., June 9 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today preliminary results from its Phase 2a proof-of-concept clinical trial with AZ-002 (Staccato(R) alprazolam) in patients with panic disorder. The study did not meet its two primary endpoints, which were the effect of AZ-002 on the incidence of a doxapram-induced panic attack and the effect of AZ-002 on the duration of a doxapram-induced panic attack, both as compared with placebo. There were no serious adverse events in the clinical trial, and AZ-002 was safe and well tolerated in the study patient population. AZ-002 is being developed through Symphony Allegro, a development collaboration formed between Alexza and Symphony Capital LLC in 2006.

The Company also announced today, in a separate news release, that it has completed enrollment of its first Phase 3 clinical trial with AZ-004 (Staccato loxapine)for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. Alexza will host an investor conference call to discuss today's announcements on Monday, June 9, 2008 at 5:15 p.m. Eastern Time.

"The failure to reach statistical significance on the primary endpoints is disappointing, but this proof-of-concept clinical trial was designed to capture data and measurements for a number of clinical parameters in this clinical setting," said James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza and chairman of the Symphony Allegro Development Board. "There is no FDA-approved therapy for the acute treatment of a panic attack or an established clinical development pathway for this potential new indication. We plan to work with our colleagues at Symphony Allegro and our ext
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SOURCE Alexza Pharmaceuticals, Inc.
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