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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

MOUNTAIN VIEW, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced positive results from its second Phase 3 clinical trial of AZ-004 (Staccato(R) loxapine). This Phase 3 clinical trial was conducted in patients with bipolar disorder experiencing acute agitation. Both the 5 mg and 10 mg doses of AZ-004 met the primary endpoint of the trial, which was a statistically significant reduction in agitation from baseline to the 2-hour post-dose time point, compared to placebo. AZ-004 is an inhalation product candidate being developed for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC.

"Alexza initiated this second Phase 3 clinical trial of our lead program in late July, completed enrollment in less than three months, and today we are reporting positive top-line results for the primary and secondary endpoints," said James V. Cassella, PhD, Alexza Senior Vice President, Research and Development. "These very strong results -- coupled with the positive data from our first Phase 3 trial in schizophrenic patients -- reinforce our belief that AZ-004 is a potentially important new drug candidate for treating acute agitation. Loxapine is a well established antipsychotic and the Staccato system enables patients to easily and painlessly self-administer the drug with a single breath and achieve therapeutic effect as quickly as an intravenous injection -- a combination of attributes that makes AZ-004 a unique potential therapeutic alternative for the acute treatment of agitation. We look forward to taking the next steps toward preparing an NDA for submission in early 2010."

Phase 3 Clinical Trial Design


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SOURCE Alexza Pharmaceuticals, Inc.
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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
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